# Article: New Drug Approach to Irritable Bowel



## Ty

http://story.news.yahoo.com/news?tmpl=stor...th_irritable_dc New Drug Approach to Irritable Bowel14 minutes ago Add Science - Reuters to My Yahoo! By Maggie Fox, Health and Science Correspondent WASHINGTON (Reuters) - A drug currently used to treat alcoholics and drug overdoses may also offer relief in a surprising quarter -- to sufferers of irritable bowel syndrome, corporate researchers said on Thursday. A small trial of 50 patients with the painful disorder showed that three-quarters of them got relief from the drug, known best as naltrexone, the company said. South San Francisco-based Pain Therapeutics Inc. said tiny doses of naltrexone, which is available generically, eased the bloating, pain, constipation and diarrhea that marked irritable bowel syndrome in both men and women. "Seventy-six percent of patients on our drug had a positive response," Remi Barbier, president and chief executive officer of Pain Therapeutics, said in a telephone interview. One in five Americans has IBS, making it one of the most common disorders diagnosed, according to the National Institute of Diabetes and Digestive and Kidney Diseases. More common in women than in men, it is not a true disease and does not cause disease, but creates a great deal of discomfort and distress. Barbier said judging the effectiveness of the drug is subjective. "It's like antidepression drugs or pain drugs -- yes, it is subjective but believe me, the symptoms of IBS are so severe that if you are better, you know it," he said. Two drugs are approved by the U.S. Food and Drug Administration (news - web sites) to treat IBS -- GlaxoSmithKline's Lotronex and Novartis AG's Zelnorm. But they are only approved for women and for short-term use. The institute also recommends stress reduction training and relaxation therapies, such as meditation, walking, yoga and getting enough sleep, as IBS seems to be aggravated by stress. Naltrexone, which Pain Therapeutics is testing under the name PTI-901, takes a new approach to treating IBS. "The traditional view of IBS is that the flusher is broken -- it is either flushing too quickly or not quickly enough, causing diarrhea or constipation," Barbier said. "We disagree with that point of view. We don't think the flusher is the problem. We think it is an imbalance of opioids in the gut. We provide the patient with an external source of opioid antagonists to restore bowel function." The phase II test was designed mostly to assess safety, and the company now plans to start a larger, Phase III efficacy trial -- the last step before seeking FDA approval. "We believe a safe and effective drug to treat both men and women who suffer from IBS represents a $1 billion market opportunity in the United States alone," Barbier said. Barbier said scientists working with his company stumbled on the opioid-IBS connection when they compared notes on patients who had overdosed on morphine or heroin, both opiate drugs. "Patients who overdose on morphine lean over and hang on to their stomach," Barbier said. "The light bulb went on. Maybe opioid withdrawal and IBS are one and the same symptoms, which is an imbalance of opioids in the gut."


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## nmwinter

> quote: We think it is an imbalance of opioids in the gut


is this similar to saying an imbalance of serotonin, I wonder?nancy


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## Ty

Nancy, ya know, I was thinking the same thing. I was interested in the fact that it says it's for D and C. But since the trials have just begun, who knows what it would be approved for.


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## Jleigh

Very interesting. Jleigh


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## kac123

This is the first i've heard of this drug -- did a quick google search on it -- http://www.lowdosenaltrexone.org/


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## trbell

fascinating, they're deaing with opiods but I would be cautious as I think some of these opiods increase constipation? check in that forum or maybe flux has some ideas on this? Does Yahoo give a citation to the original research? Yahoo isn't known for accuracy?tom


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## trbell

If true this is something a psychiatrist or GP could prescribe right now off label, I would think?tom


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## trbell

I'm pretty sure this drug has been around for quite some time and any MD can prescribe it, I think the way seroto0nin is related is that serotonin actually affects opiod levels in the guts, but I'd ike to hear more from somone who knows haow these things work.tomalso explains why some antidepressants work for some and not all I suspect.


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## androsine

New Drug Approach to Irritable Bowel2 hours, 51 minutes ago Add Science - Reuters to My Yahoo! By Maggie Fox, Health and Science Correspondent WASHINGTON (Reuters) - A drug currently used to treat alcoholics and drug overdoses may also offer relief in a surprising quarter -- to sufferers of irritable bowel syndrome, corporate researchers said on Thursday. A small trial of 50 patients with the painful disorder showed that three-quarters of them got relief from the drug, known best as naltrexone, the company said. South San Francisco-based Pain Therapeutics Inc. said tiny doses of naltrexone, which is available generically, eased the bloating, pain, constipation and diarrhea that marked irritable bowel syndrome in both men and women. "Seventy-six percent of patients on our drug had a positive response," Remi Barbier, president and chief executive officer of Pain Therapeutics, said in a telephone interview. One in five Americans has IBS, making it one of the most common disorders diagnosed, according to the National Institute of Diabetes and Digestive and Kidney Diseases. More common in women than in men, it is not a true disease and does not cause disease, but creates a great deal of discomfort and distress. Barbier said judging the effectiveness of the drug is subjective. "It's like antidepression drugs or pain drugs -- yes, it is subjective but believe me, the symptoms of IBS are so severe that if you are better, you know it," he said. Two drugs are approved by the U.S. Food and Drug Administration (news - web sites) to treat IBS -- GlaxoSmithKline's Lotronex and Novartis AG's Zelnorm. But they are only approved for women and for short-term use. The institute also recommends stress reduction training and relaxation therapies, such as meditation, walking, yoga and getting enough sleep, as IBS seems to be aggravated by stress. Naltrexone, which Pain Therapeutics is testing under the name PTI-901, takes a new approach to treating IBS. "The traditional view of IBS is that the flusher is broken -- it is either flushing too quickly or not quickly enough, causing diarrhea or constipation," Barbier said. "We disagree with that point of view. We don't think the flusher is the problem. We think it is an imbalance of opioids in the gut. We provide the patient with an external source of opioid antagonists to restore bowel function." The phase II test was designed mostly to assess safety, and the company now plans to start a larger, Phase III efficacy trial -- the last step before seeking FDA approval. "We believe a safe and effective drug to treat both men and women who suffer from IBS represents a $1 billion market opportunity in the United States alone," Barbier said. Barbier said scientists working with his company stumbled on the opioid-IBS connection when they compared notes on patients who had overdosed on morphine or heroin, both opiate drugs. "Patients who overdose on morphine lean over and hang on to their stomach," Barbier said. "The light bulb went on. Maybe opioid withdrawal and IBS are one and the same symptoms, which is an imbalance of opioids in the gut."


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## trbell

has anyone tried this yet? I do know opiods have been looked at for IBS.tom


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## nmwinter

I know I've read of some people on this board who've used opoids and gotten relief. nancy


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## vere76

Low Dose NaltrexoneFDA-approved naltrexone, in a low dose, can boost the immune system - helping those with HIV/AIDS, cancer, and autoimmune diseases. --------------------------------------------------------------------------------Welcome to the Low Dose Naltrexone (LDN) Home PageLatest News May 2003 + The Developing Nations Project + A humanitarian effort to respond to the AIDS pandemic -------------------------------------------------------------------------------- NEW! For announcements and discussion about Low Dose Naltrexone,subscribe to the LDN Yahoo Group: The LDN Yahoo Group is an announcement and discussion group for those interested in LDN, and who wish to be notified about updates to this website. We expect that official announcements to the group will be fairly infrequent, typically not more than one per month. Group members not wishing to receive general discussion e-mail from other members may set their message delivery option to "Special Notices" when joining, or by logging on to the LDN Yahoo Group site and clicking on "Edit My Membership."--------------------------------------------------------------------------------> On this page you can find answers to these questions:What is low-dose naltrexone and why is it important? How does LDN work? What diseases has it been useful for? How can I obtain LDN and what will it cost? What dosage and frequency should my physician prescribe? Are there any side effects or cautionary warnings? When will the low-dose use of naltrexone become FDA approved? What can I do to spread the word about LDN? Who sponsored this website? > You can go to more detailed information on these linked pages:The Latest News Concerning LDN LDN in the Treatment of Autoimmune Disease LDN in the Treatment of Cancer LDN in the Treatment of HIV/AIDS In-depth historical reports on LDN for HIV/AIDS: "Low Dose Naltrexone in the Treatment of Acquired Immune Deficiency Syndrome," a paper presented in 1988 to the International AIDS Conference in Stockholm, Sweden, describing in detail the 1986 LDN HIV/AIDS clinical study. "Low Dose Naltrexone in the Treatment of HIV Infection," an informal description of the results in Dr. Bernard Bihari's private practice through September, 1996. LDN in the Treatment of Multiple Sclerosis Further Questions and Answers about LDN The Developing Nations Project Curriculum Vitae for Bernard Bihari, M.D. Excerpts from Patient Interviews: LDN and HIV The Developing Nations Project --------------------------------------------------------------------------------What is low-dose naltrexone and why is it important?> Low-dose naltrexone holds great promise for the millions of people worldwide facing a possible death sentence from virtually incurable cancers and other diseases. > In the developing world, LDN could provide the first low-cost, easy to administer, and side-effect-free therapy for HIV/AIDS.Naltrexone itself was approved by the FDA in 1984 in a 50mg dose for the purpose of helping heroin or opium addicts, by blocking the effect of such drugs. By blocking opioid receptors, naltrexone also blocks the reception of the opioid hormones that our brain and adrenal glands produce: beta-endorphin and metenkephalin. Many body tissues have receptors for endorphins and enkephalins, including virtually every cell of the body's immune system. In 1985, Bernard Bihari, MD, a physician with a clinical practice in New York City, discovered the effects of a much smaller dose of naltrexone (approximately 3mg once a day) on the body's immune system. He found that this low dose, taken at bedtime, was able to enhance a patient's response to infection by HIV, the virus that causes AIDS. [Note: Subsequently, the optimal adult dosage of LDN has been found to be 4.5mg.]In the mid-1990's, Dr. Bihari found that patients in his practice with cancer (such as lymphoma or pancreatic cancer) could benefit, in some cases dramatically, from LDN. In addition, people who had autoimmune disease (such as lupus) often showed prompt control of disease activity while taking LDN.As of March 2001, Dr. Bihari has been treating 175 AIDS patients using LDN in conjunction with accepted AIDS therapies. Over the past 4 years over 85% of these patients showed no detectable levels of the HIV virus - a much higher success rate than most current AIDS treatments, and with no significant side effects. It is also worth noting that many HIV/AIDS patients under Dr. Bihari's care have been living symptom-free for years taking only LDN with no other medications.--------------------------------------------------------------------------------How does LDN work? > LDN boosts the immune system, activating the body's own natural defenses.The brief blockade of opioid receptors that is caused by taking LDN at bedtime each night is believed to produce a prolonged up-regulation of vital elements of the immune system by causing an increase in endorphin and enkephalin production. Normal volunteers who have taken LDN in this fashion have been found to have much higher levels of beta-endorphins circulating in their blood in the following days. Animal research by I. Zagon, Ph.D., and his colleagues has shown a marked increase in metenkephalin levels as well. [Note: Additional information for Dr. Zagon can be found at the end of this page.]Bihari says that his patients with HIV/AIDS who regularly took LDN before the availability of HAART were generally spared any deterioration of their important helper T cells (CD4+). In human cancer, research by Zagon over many years has demonstrated inhibition of a number of different human tumors in laboratory studies by using endorphins and low dose naltrexone. It is suggested that the increased endorphin and enkephalin levels, induced by LDN, work directly on the tumors' opioid receptors - and, perhaps, induce cancer cell death (apoptosis). In addition, it is believed that they act to increase natural killer cells and other healthy immune defenses against cancer. In general, in people with diseases that are partially or largely triggered by a deficiency of endorphins (including cancer and autoimmune diseases), restoration of the body's normal production of endorphins is the major therapeutic action of LDN.--------------------------------------------------------------------------------What diseases has it been useful for? Bernard Bihari, MD has described beneficial effects of LDN on a variety of diseases:Cancers: Other Diseases: Breast Cancer ALS (Lou Gehrig's Disease) Carcinoid Behcet's Disease Colon & Rectal Cancer Chronic Fatigue Syndrome Glioblastoma Crohn's Disease Liver Cancer Fibromyalgia Lymphocytic Leukemia HIV/AIDS Lymphoma (Hodgkin's and Non-Hodgkin's) Multiple Sclerosis (MS) Malignant Melanoma Parkinson's Disease Multiple Myeloma Pemphigoid Neuroblastoma Psoriasis Non-Small Cell Lung Cancer Rheumatoid Arthritis Ovarian Cancer Systemic Lupus (SLE) Pancreatic Cancer Wegener's Granulomatosis Prostate Cancer (untreated) Renal Cell Carcinoma Throat Cancer Uterine Cancer How is it possible that one medication can impact such a wide range of disorders? The disorders listed above all share a particular feature: in all of them, the immune system plays a central role - and low blood levels of endorphins are generally present, playing a role in the disease-associated immune deficiencies. Research by others - on neuropeptide receptors expressed by various human tumors - has found opioid receptors in many types of cancer:Brain tumors (both astrocytoma and glioblastoma) Breast cancer Endometrial cancer Head and neck squamous cell carcinoma Myeloid leukemia Lung cancer (both small cell and non-small cell) Neuroblastoma These findings suggest the possibility for a beneficial LDN effect in a wide variety of common cancers. --------------------------------------------------------------------------------


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## Jennifer7

This is interesting. My prescription of Zofran says it may be used to treat alcoholism.Jennifer


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## trbell

thanks for the information. It seems to improve the immune system?tom


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## vere76

Pain Therapeutics' New Drug Markedly Improved Patients With Irritable Bowel Syndrome (IBS) Company's First Clinical Results in IBS With a New Class of DrugsSOUTH SAN FRANCISCO, Calif., May 29 /PRNewswire-FirstCall/ -- Pain Therapeutics, Inc. (Nasdaq: PTIE), announced today that PTI-901, the first of a new class of drugs developed to treat irritable bowel syndrome, significantly improved all the common symptoms associated with IBS.In a 50 patient pilot clinical study, patients of both gender reported a response rate of 76.2% at the conclusion of the four-week study (N=42). The magnitude of the benefit far exceeded what this pilot study was designed to demonstrate. The study also met the secondary endpoints of improving daily abdominal pain, bowel habits and stool consistency. These improvements were observed in patients whose baseline symptoms were either diarrhea or constipation, or both. No drug-related adverse events were observed."This study met its primary endpoint," said Remi Barbier, president and chief executive officer of Pain Therapeutics, Inc. "These results reinforce our faith that PTI-901 has the potential to become the standard drug therapy for patients who suffer from IBS. We believe a safe and effective drug to treat both men and women who suffer from IBS represents a $1 billion market opportunity in the United States alone."The male and female response rate was 76.5% (N=17) and 75.0% (N=25) respectively. In addition, patients on PTI-901 reported a 193% increase in number of pain-free days at Week 4 compared to baseline (N=37). Significant clinical improvements in bowel urgency, stool consistency and number of stools per day were also reported at Week 4 in both genders. PTI-901 was well tolerated by all patients during the entire treatment period."In this study, PTI-901 had a clean safety profile and provided rapid and sustained relief of abdominal pain for patients with IBS," added Nadav Friedmann, Ph.D., MD, chief medical and operating officer of Pain Therapeutics, Inc. "Significantly, these clinical benefits were observed in IBS patients regardless of gender. These data encourage us to evaluate PTI-901 in a Phase III trial designed to support product approval."Pain Therapeutics believes this study presents clinical validation of the novel hypothesis that IBS patients suffer from an abnormal imbalance of opioid activity in the gut. Such an imbalance may be triggered by emotional stress, metabolic disorders or intrinsic release of opioids from gut neurons. The Company and its scientific collaborators believe that chronic administration of very low doses of an opioid antagonist, such as the investigational new drug PTI-901, restores the proper level of opioid activity in the gut. This relieves abdominal pain and other symptoms frequently observed in patients with IBS. The Company holds exclusive, worldwide commercial rights in a family of issued patents and patent applications, including two issued U.S. patents in this area.Pain Therapeutics and its principal investigator intend to submit an abstract of this trial to the Annual Scientific Meeting of the American College of Gastroenterology, which will be held in Baltimore in October 2003. The Company plans to follow-up this pilot clinical study with a 600 patient Phase III pivotal trial in the United States. The Company's registration strategy will ultimately depend on PTI-901's level of activity in pivotal Phase III studies and on discussions with regulatory agencies.Study DetailThe purpose of this open-label study was to evaluate the clinical effects of PTI-901 (low-dose naltrexone HCI) in patients with IBS. A total of 50 patients were enrolled. All patients were diagnosed with IBS by a gastroenterologist according to Rome II Criteria. Treatment consisted of 0.5 mg dose of PTI-901 daily over a four-week period. Patients were evaluated for abdominal pain, bowel habits and stool consistency at baseline and at the end of weeks 1 through 4. The primary efficacy endpoint was the patients' observations of Global Assessment of Adequacy of Treatment. Secondary efficacy endpoints included abdominal pain and bowel habits. The study was conducted at the Sourasky Medical Center in Israel under an Investigational New Drug (IND) Application filed with the U.S. Food and Drug Administration (FDA).Existing IBS DrugsThe FDA has approved two drugs to treat women with certain types of IBS (no drug therapy is currently FDA approved for men with IBS): GlaxoSmithKline's Lotronex(tm) and Novartis' Zelnorm(tm). According to Physicians' Desk Reference, the response rate and placebo rate for women on Lotronex(tm) are approximately 50% and 35% respectively at Week 4. The response rate and placebo rate for women on Zelnorm(tm) are approximately 58% and 50% respectively at Week 4.About Irritable Bowel Syndrome (IBS)IBS is a chronic, painful abdominal disorder that leads to major changes in bowel habits. IBS causes some patients to have constipation, diarrhea or in some cases both. The cause of IBS is not known, and as yet there is no cure. People with chronic IBS may be unable to attend social events, hold a job, or travel away from home. Over 10 percent of the U.S. population suffers from IBS. For unknown reasons, IBS predominantly affects women.About Pain Therapeutics, Inc.We are a medical research company specializing in the discovery and development of novel proprietary painkillers. We believe one of our lead drug candidates, Oxytrex(tm), may offer more pain relief (with no increase in side-effects) or lower tolerance/dependence, withdrawal effects or addiction potential compared to conventional forms of oxycodone. The market for oxycodone exceeded $1.5 billion in the United States in 2002. Another drug candidate, PTI-901, is aimed at treating patients who suffer from abdominal pain associated with Irritable Bowel Syndrome


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## trbell

I think the important thing here is that this is one of a class of drugs and should be something any md can prescribe off label as it only takes a little bit and it seems to work for bloating?tom


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## Vicky19

can someone pls explain to me why it wont work in all cases?i take an anti depressant and have done for 5 wks but am not relieved of all the tummy pain. i know i should give it a longer time to work though.


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## WD40

Very intriguing post!


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## trbell

If I remember correct, WD you are a vet, too. I asked at the VA yesterday and found 5 others who had a history of heavy alcohol use (I'm not putting you in this class) and now have IBS. Maybe there is something to the idea that alcohol destroys the immune system? That's what this drug seems to work on.tom


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## trbell

this might explain why a little wine might help.tom


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## vere76

My doc just gave me a Rx but I havent had it fill , i will keed you up to date


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## trbell

Is this for naltrexone?tom


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## B.B.

Hi. This is my first time here, so be gentle!I received the press release that's been printed in the messages above regarding naltrexone.I just spoke with the drug company that did the trial, Pain Therapeutics, and they explained that they don't expect to start Phase III trials until 2004. Geez!They did forward me more detailed info, that explains that the very successful test that they did was based on prescribing 0.5 mg. dose of PTI-901 daily over a four-week period.Okay, here's the question. The article about this trial states that "Naltrexone, which Pain Therapeutics is testing under the name PTI-901...". So, does 0.5 mg. dose of PTI-901 mean the same as a 0.5 mg. dose of Naltrexone? If so, then I suppose I could get my doctor to prescribe it off-label right now.Any thoughts?Thanks,Brad


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## trbell

Brad, I think you're right and the more information you can share with us the better. Natrexone has been around a long time and there's really no reason any doc woudn't prescibe it for the immune effects if these are true.tom


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## trbell

if you get press releases, Brad, maybe you have some info for the news forum?tom


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## B.B.

Hi. I found the press release on the company's website: www.paintrials.com .The article that I found was from MSNBC's website and it is dated May 29th, and has a title of "Drug may treat irritable bowel".When I spoke with them, the company, Pain Therapeutics, said that one of the reasons that the trial might not start until 2004 is that they needed to make sure they had enough money to the do the Phase III. That sounds odd, giving how big a market there would be for this. Also, I've never heard of a company getting a patent on existing medication, and based solely on the fact that their dosage level is smaller than the dosage used for treating substance abuse problems. I didn't think that qualifies for a new patent.But hey, if they can get the patent, and deliver on a way of helping with IBS, that works for me!I wonder if insurance plans will cover a prescription for naltrexone for this purpose, or if they'll consider it "experimental."Brad


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## trbell

FDA approva and patents are about making money. That's probably why they didn't publicize this earlier. Its also going to pump up the cost. In the meantime a low dose prescription can be written by any md.tom


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## Vicky19

why wont don't anti depressants work for all ppl?


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## trbell

there are a lot of antidepressants and a lot of different people.tom


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## vikee

To Everyone who posted above....Thank You! Thank You!!I have gone to all the web sites and printed out information to give to my Doctor! I hope to get Naltrexone soon.I also joined the Yahoo Group LDN (low dose Naltrexone) by clicking on the link in the Yahoo Article.Let's keep this thread alive for for reactions to taking LDN! And also be prepared for it not to work for everyone! I hate to be disappointed once again so my expectations are low! There will be no placebo effect for me! But one never knows......


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## vikee

Tom, I found this but don't know if the Organization is reliable:


> quoteain Therapeutics' New Drug Markedly Improved Patients With Irritable Bowel Syndrome (IBS) Company's First Clinical Results in IBS With a New Class of DrugsSOUTH SAN FRANCISCO, Calif., May 29 /PRNewswire-FirstCall/ -- Pain Therapeutics, Inc. (Nasdaq: PTIE), announced today that PTI-901, the first of a new class of drugs developed to treat irritable bowel syndrome, significantly improved all the common symptoms associated with IBS.In a 50 patient pilot clinical study, patients of both gender reported a response rate of 76.2% at the conclusion of the four-week study (N=42). The magnitude of the benefit far exceeded what this pilot study was designed to demonstrate. The study also met the secondary endpoints of improving daily abdominal pain, bowel habits and stool consistency. These improvements were observed in patients whose baseline symptoms were either diarrhea or constipation, or both. No drug-related adverse events were observed."This study met its primary endpoint," said Remi Barbier, president and chief executive officer of Pain Therapeutics, Inc. "These results reinforce our faith that PTI-901 has the potential to become the standard drug therapy for patients who suffer from IBS. We believe a safe and effective drug to treat both men and women who suffer from IBS represents a $1 billion market opportunity in the United States alone."The male and female response rate was 76.5% (N=17) and 75.0% (N=25) respectively. In addition, patients on PTI-901 reported a 193% increase in number of pain-free days at Week 4 compared to baseline (N=37). Significant clinical improvements in bowel urgency, stool consistency and number of stools per day were also reported at Week 4 in both genders. PTI-901 was well tolerated by all patients during the entire treatment period."In this study, PTI-901 had a clean safety profile and provided rapid and sustained relief of abdominal pain for patients with IBS," added Nadav Friedmann, Ph.D., MD, chief medical and operating officer of Pain Therapeutics, Inc. "Significantly, these clinical benefits were observed in IBS patients regardless of gender. These data encourage us to evaluate PTI-901 in a Phase III trial designed to support product approval."Pain Therapeutics believes this study presents clinical validation of the novel hypothesis that IBS patients suffer from an abnormal imbalance of opioid activity in the gut. Such an imbalance may be triggered by emotional stress, metabolic disorders or intrinsic release of opioids from gut neurons. The Company and its scientific collaborators believe that chronic administration of very low doses of an opioid antagonist, such as the investigational new drug PTI-901, restores the proper level of opioid activity in the gut. This relieves abdominal pain and other symptoms frequently observed in patients with IBS. The Company holds exclusive, worldwide commercial rights in a family of issued patents and patent applications, including two issued U.S. patents in this area.Pain Therapeutics and its principal investigator intend to submit an abstract of this trial to the Annual Scientific Meeting of the American College of Gastroenterology, which will be held in Baltimore in October 2003. The Company plans to follow-up this pilot clinical study with a 600 patient Phase III pivotal trial in the United States. The Company's registration strategy will ultimately depend on PTI-901's level of activity in pivotal Phase III studies and on discussions with regulatory agencies.Study DetailThe purpose of this open-label study was to evaluate the clinical effects of PTI-901 (low-dose naltrexone HCI) in patients with IBS. A total of 50 patients were enrolled. All patients were diagnosed with IBS by a gastroenterologist according to Rome II Criteria. Treatment consisted of 0.5 mg dose of PTI-901 daily over a four-week period. Patients were evaluated for abdominal pain, bowel habits and stool consistency at baseline and at the end of weeks 1 through 4. The primary efficacy endpoint was the patients' observations of Global Assessment of Adequacy of Treatment. Secondary efficacy endpoints included abdominal pain and bowel habits. The study was conducted at the Sourasky Medical Center in Israel under an Investigational New Drug (IND) Application filed with the U.S. Food and Drug Administration (FDA).Existing IBS DrugsThe FDA has approved two drugs to treat women with certain types of IBS (no drug therapy is currently FDA approved for men with IBS): GlaxoSmithKline's Lotronex(tm) and Novartis' Zelnorm(tm). According to Physicians' Desk Reference, the response rate and placebo rate for women on Lotronex(tm) are approximately 50% and 35% respectively at Week 4. The response rate and placebo rate for women on Zelnorm(tm) are approximately 58% and 50% respectively at Week 4.About Irritable Bowel Syndrome (IBS)IBS is a chronic, painful abdominal disorder that leads to major changes in bowel habits. IBS causes some patients to have constipation, diarrhea or in some cases both. The cause of IBS is not known, and as yet there is no cure. People with chronic IBS may be unable to attend social events, hold a job, or travel away from home. Over 10 percent of the U.S. population suffers from IBS. For unknown reasons, IBS predominantly affects women.About Pain Therapeutics, Inc.We are a medical research company specializing in the discovery and development of novel proprietary painkillers. We believe one of our lead drug candidates, Oxytrex(tm), may offer more pain relief (with no increase in side-effects) or lower tolerance/dependence, withdrawal effects or addiction potential compared to conventional forms of oxycodone. The market for oxycodone exceeded $1.5 billion in the United States in 2002. Another drug candidate, PTI-901, is aimed at treating patients who suffer from abdominal pain associated with Irritable Bowel Syndrome. For more information, please visit our website at www.paintrials.com.Note Regarding Forward-Looking Statements: This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 and it is Pain Therapeutics' intent that such statements be protected by the safe harbor created thereby. Examples of such statements include, but are not limited to, any statements relating to the potential benefits of PTI-901 for the treatment of IBS, the size, scope, goals, or timing of the Company's pivotal trial with PTI-901, the benefits that may be derived from the Company's patents or technology, the potential benefits of the Company's drug candidates, and the size of the potential market for the Company's products. Such statements are based on management's current expectations, but actual results may differ materially due to various factors, including, but not limited to, risks and uncertainties relating to difficulties or delays in development, enrolling and conducting clinical trials such as the IBS study, regulatory approval, production and marketing of the Company's drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates that could slow or prevent product approval (including the risk that current and past results of clinical trials are not necessarily indicative of future results of clinical trials), the uncertainty of patent protection for the Company's intellectual property or trade secrets and the Company's ability to obtain additional financing if necessary. For further information regarding these and other risks related to the Company's business, investors should consult the Company's filings with the Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2002 and its subsequent quarterly filings.SOURCE Pain Therapeutics, Inc.CONTACT: Christi Waarich, Manager of Investor Relations of Pain Therapeutics, Inc., +1-650-825-3324, or cwaarich###paintrials.comWeb site: http://www.paintrials.com http://www.prnewswire.com


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## trbell

thanks for the info. I'm going to ask my doctor about naltrexone.tom


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## trbell

can you paste the link for the group for the rest of us? Since it seems to improve immune functioing it may also help with other problems.tom


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## Susan Purry

Interesting Ty, thanks for posting.


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## vikee

This link has information and allows one to sign up for a Yahoo LDN (Low Dose Naltrexone) group: http://www.lowdosenaltrexone.org/ This link may be already posted, it is short": http://news.yahoo.com/news?tmpl=story2&cid...le_dc&printer=1 Here is another link I found: http://www.corporate-ir.net/ireye/ir_site....&item_id=416919 One of my Doctors said not now regarding Naltrexone, he needs to read the original research articles and wait for FDA approval.Two more Doctors to ask. In addition to IBS I have MS, so I wonder what my Neurologist will say at my appointment next month. I have to set up an appointment with my GI Doctor. Not sure of his reaction.Getting the low dose now without FDA approval requires a Pharmacy that will prepare the 4.5mg (or lower) dose from the 30 mg one. A list of Pharmacies that are known to do this is given as you read what is on the first web site I posted above (Yahoo).


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## trbell

I think your doctor is right in wanting to read the original research rather than just one study. tom


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## SPAIN

Hello every body!!In first place sorry because my inglish is poor. (I came from Spain.)I Think that this "very low dosage" of naltrexone may have a important avance. If this could work, Why wait? I canï¿½t wait! Now iï¿½m experimenting in my self. I made a solution whit distilled water and 0,5 mg of naltrexone in order to test. Itï¿½s because this "very low" dosage canï¿½t be dangerous efects. Really this dosage is insignificant is one hundredth part of normal dosage, this is, with only a normal dosis you have for hundred days, so i say "very very low dosage" itï¿½s sound increible how so little drip can be relieve IBS, itï¿½s like homeopathy and perhaps homeopathy could explain the cause that this works, who knows? This coold be that LDN restore inmune system, Itï¿½s no clear, perhaps are important the relation with the peptides,... Iï¿½s a great new, because this makes me hope and sure one day the IBS will not be a problen.Also you must be precautious but not sceptic. This is may day 3 in LDN and i donï¿½t see changes, but is to soon. I will inform you about the progress when i have news. I donï¿½t hope nothing but who knows? greetings !


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## vere76

SPAIN Are you IBS-D OR C


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## trbell

I' going to get an md to prescribe it but any md can do it now.tom


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## SPAIN

Vere76, normally Iï¿½m IBS-D, although some times C and D


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## Guest

so do they think we have too much opiate in our systems. or our receptors are too sensitive? or not enough/not sensitive enough receptors? also, its interesting that this drug is effective on diarrhea and constipation(not to mention the other symtpoms. is there any other drug that works on these two very different expressions of ibs? if this is true(skeptical again), i'd say atleast we are getting closer to the core problem of ibs. but that would mean that there really is something that defines ibs(skeptical about this too). i'm just hoping/waiting/seeing. zelnorm was touted as very helpful too, but few have gotten anything lasting out of it---not to mention most other ibs drugs on the market that drug companies think are helping us-not!


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## zayaka26

SPAIN, I sent you a private message.


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## trbell

it's hard to say about lotronex and Zelnorm. People that were helped might just not be posting?tom


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## wb

i asked the VA today for this and they stated they didn't carry it. go figure. seems expensive on some sites on the internet but at the rate ibs is knocking me down i'll pay it.


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## 17069

The part about IBS being caused by opiod imbalance makes sence to me. Think of how common opium use was on the planet thousands of years ago, and how common IBS is. It was like the first medicine and was used for everything from pain to asthma not too long ago. I'll bet everyone on the planet is descended from at least one opium user if not hundreds, or thousands, or more. All those generations could be enough time to create some sort of genetic dependcy in order to achieve proper bowel function. Is IBS one of those new development type of disorders? I guess this would depend on that.


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