# Positive Clinica Data In IBS presented at Gastroenterology Meeting(from Spasman)



## KariGaglione (Aug 13, 2003)

Pain Therapeutics, Inc. For More Information Contact: Christi Waarich Kathy L. Jones, Ph.D. (Media) Manager of Investor Relations Burns McClellan Pain Therapeutics, Inc. 212-213-0006 cwaarich###paintrials.com 650-825-3324 FOR IMMEDIATE RELEASEPOSITIVE CLINCAL DATA IN IRRITABLE BOWEL SYNDROME TO BE PRESENTED AT GASTROENTEROLOGY MEETING SOUTH SAN FRANCISCO, Calif. ï¿½October 15, 2003 ï¿½ Pain Therapeutics, Inc. (Nasdaq: PTIE), a biopharmaceutical company, announced its clinical data with PTI-901 is being presented today at the Scientific Meeting of the American College of Gastroenterology in Baltimore, Maryland. PTI-901 is the first in a new class of drugs the Company is developing to treat men or women with irritable bowel syndrome (IBS). Zamir Halpern, M.D., the Head of the Department of Gastroenterology at the Sourasky Medical Center in Israel, and his colleagues will present a clinical poster titled ï¿½PTI-901 For The Treatment of Irritable Bowel Syndrome.ï¿½ Dr. Halpern was Principal Investigator of a previously announced clinical study in which patients with IBS reported a 76% response rate to PTI-901. ï¿½Current pharmacological treatments are inadequate for patients with IBS,ï¿½ said Dr. Halpern. ï¿½In this study, PTI-901 provided lasting clinical benefits in patients suffering from chronic IBS. In particular, I am impressed with PTI-901ï¿½s ability to improve patientsï¿½ well-being and to relieve abdominal pain. These clinical improvements were observed in men and women and occurred without drug-related safety issues. Taken together, these clinical data with PTI-901 encourage a large, randomized, placebo controlled study in men and women with IBS.ï¿½ Pain Therapeutics and the U.S. Food and Drug Administration (FDA) recently met to discuss the Companyï¿½s progress with PTI-901. As a direct result of these discussions, the Company plans to initiate a Phase III pivotal program in men and women with IBS in December 2003 in the U.S. -more- 416 Browning Way South San Francisco, CA 9080 4Phone: 650-624-8200 Fax: 650-624-8222 Pain Therapeutics, Inc. October 15, 2003 Page 2 of 3 Study Design and Clinical Results This open-label study was designed to assess the safety and efficacy of PTI-901 in IBS patients. A total of 50 male or female patients, all diagnosed with IBS by a gastroenterologist according to Rome II Criteria, were enrolled in the study. Treatment consisted of a 0.5 mg dose of PTI-901 given daily over a four-week period. Patients were evaluated for global response to treatment, abdominal pain, bowel habits and stool consistency at baseline, in weeks 1 through 4 and during a subsequent four-week follow-up period. The study was conducted by the staff at the Department of Gastroenterology and Liver Disease at the Sourasky Medical Center in Israel, under an Investigational New Drug (IND) Application filed with the FDA by the Company. The efficacy of PTI-901 was assessed in weeks 1 through 4 using the patientsï¿½ observations of ï¿½Global Assessment of Adequacy of Treatment.ï¿½ The primary endpoint was prospectively defined as patients reporting a weekly global assessment score of fair or better at week 4 compared to baseline. The male and female response rate to the primary endpoint was 77.8% (N=18) and 75% (N=28) respectively. Secondary efficacy endpoints included measurements of abdominal pain and bowel habits. Patients taking PTI-901 reported over 140% increase in number of pain-free days at week 4 compared to baseline (N=42). 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. About PTI-901 PTI-901 (low-dose naltrexone HCI) is Pain Therapeuticsï¿½ novel drug candidate to treat men or women with IBS. It is believed that an imbalance of opioid activity in the gut contributes to the symptoms that comprise IBS. Such an imbalance may be triggered by emotional stress, metabolic disorders or intrinsic release of opioids from neurons in the gut. PTI-901 is the first in a new class of drugs called opioid antagonists designed to restore the balance of opioid activity in the gut. By restoring this imbalance, PTI-901 relieves abdominal pain and other symptoms frequently observed in patients with IBS. Pain Therapeutics holds exclusive, worldwide commercial rights to a family of issued patents and patent applications directed to the long-term treatment of IBS patients with proprietary opioid antagonists, such as PTI-901. About Irritable Bowel Syndrome 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 biopharmaceutical company specializing in the clinical development of novel painkillers. We believe our unique insights into the biology and biochemistry of pain will allow us to develop new drugs that address unmet needs in pain management. PTI-901 is a small molecule drug to treat IBS. We believe a safe and efficacious drug to treat IBS represents a $1 billion market opportunity. Another drug candidate, Oxytrexï¿½, a small molecule drug to treat severe chronic pain, is currently in Phase III clinical development. Our clinical studies indicate that Oxytrex offers more pain relief with no increase in side-effects, compared to opioid painkillers, such as oxycodone. The market for oxycodone exceeded $1.5 billion in the United States in 2002. For more information, please visit our website at www.paintrials.com. -more- Pain Therapeutics, Inc. October 15, 2003 Page 3 of 3 Note Regarding Forward-Looking Statements: This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the ï¿½Actï¿½). PTI disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, any statements relating to the timing, scope or expected outcome of the Company's clinical development of its drug candidates, the potential benefits of the Companyï¿½s drug candidates, and the size of the potential market for the Companyï¿½s products. Such statements are based on management's current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, 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 or market acceptance (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, the Company's ability to obtain additional financing if necessary and unanticipated research and development and other costs. 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 S-3 as amended, filed September 22, 2003. ###


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## JeanieK (Nov 26, 2003)

woo hooooooo


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## IBS2 (Feb 7, 1999)

Since Naltrexone is already an available drug, does this report of its success mean physicians are free to dispense the med now?Tom


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## alfonsotexas (Sep 23, 2002)

To Tom:Naltrexone only comes in 50mg caps. The dosage for IBS is 1/2mg per day. You could get the drug now, however you would have to grind up a pill, mix it with, I guess water would be best, so that you would get a 1/2mg dose in, say in a table spoon. Alan


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## SpAsMaN* (May 11, 2002)

One of my G.I. specialist agreed to prescribe me 12 mg of Naltrexone.Unfortunany,even .5mg was causing not head ache but behind the eyes aches.So i stopped it.Maybe another drug can help with that,i don't know.You have to find a pharma lab to make it.A good pharmacist knows where.


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