# Zelnorm(R) May Be a Safe and Effective Treatment for Patients With Mixed IBS



## Jeffrey Roberts (Apr 15, 1987)

Study Reveals Zelnorm® May Be a Safe and Effective Treatment for Additional Group of IBS Patients With a Mixed Bowel Pattern * First study to identify a potential safe and efficacious medical treatment for patients with IBS-M * The study concludes that Zelnorm is safe and effective in treating the overall symptoms in IBS-M and IBS-C patients * A recent study of IBS sufferers published in Gastroenterology revealed that nearly 1/3 of participants experienced IBS-M LOS ANGELES, May 22 /PRNewswire/ -- Novartis today announced studyresults showing promise for Zelnorm® (tegaserod maleate) as a safe andefficacious medical treatment for patients with Irritable Bowel Syndromewith a mixed bowel pattern (IBS-M). This is the first study to identify apotential treatment option for patients who suffer from IBS-M. The findingswere presented at Digestive Disease Week 2006. IBS is a dysmotility and sensory disorder characterized by abdominalpain or discomfort, bloating, and altered bowel function. Based on Rome IIcriteria, IBS patients are classified based on their primary bowelcomplaint as either IBS with Constipation (IBS-C) or IBS with Diarrhea(IBS-D). Those IBS sufferers who do not fulfill scientifically basedstandards for either IBS-C or IBS-D can exhibit a mixed bowel pattern, orIBS-Mixed (IBS-M). A recent study of IBS sufferers published inGastroenterology revealed that nearly one third of participants experiencedIBS-M.(1) "IBS patients who suffer with a mixed bowel pattern are in need of aneffective treatment option," said William Chey, M.D., Associate Professorof Medicine and Director of the GI Physiology Laboratory at the Universityof Michigan Health System. "These study results are promising as Zelnormwas shown to provide a statistically significant improvement insatisfactory relief of IBS symptoms in both the IBS-C and IBS-M groups.More than 50 percent of the IBS-M patients experienced a response totegaserod." Zelnorm is the first and only prescription medication approved by theU.S. Food and Drug Administration (FDA) for both Chronic IdiopathicConstipation and IBS with Constipation. "IBS affects millions of Americans. We are encouraged to see that inaddition to providing relief to millions of IBS with Constipation andChronic Constipation sufferers, Zelnorm may now offer hope to IBS patientswith a mixed bowel pattern," said Marielle Cohard-Radice, ExecutiveDirector, Gastroenterology, Clinical Development & Medical Affairs,Novartis Pharmaceuticals Corporation. IBS-M Study Results The study was designed to determine whether Zelnorm was safe andeffective for the treatment of IBS-M. At present, no medical therapy hasbeen demonstrated to be effective in IBS-M patients. The randomized, double-blind, placebo-controlled, multicenter studyevaluated 661 women with IBS-C (337) or IBS-M (324). Study participantswere asked to provide an assessment of satisfactory relief over four weeksof treatment with Zelnorm 6 mg b.i.d. or placebo. Also assessed, were theproportion of patients reporting satisfactory relief for greater than orequal to 3 out of 4 treatment weeks (75% rule) and improvement during eachof the 4 weeks in individual IBS symptoms. Baseline symptom assessmentclearly distinguished between IBS-C and IBS-M cohorts. Overall, Zelnorm provided statistically significant improvement insatisfactory relief of IBS symptoms over a four-week treatment for theIBS-C and IBS-M cohorts. In the two cohorts, the percentage of patientsexperiencing satisfactory relief of IBS symptoms (75% rule) wassignificantly higher for Zelnorm compared to placebo (IBS-C: 43.3% vs28.9%, p=0.008 and IBS-M: 52.3% vs 36.3%, p=0.010). Zelnorm wassignificantly superior to placebo at improving weekly bowel movementfrequency, stool consistency and straining. The most frequent adverse events were diarrhea (Z 9.4% and P 2.1%),headache (Z 5.5% and P 6.6%), abdominal pain (Z 3% and P 2.1%), and nausea(Z 2.1% and P 3.3%). Adverse event discontinuations were low for bothZelnorm and placebo groups (IBS-C: 1.2% vs 2.4% and IBS-M: 2.5% vs. 3.6%).Diarrhea was reported more frequently in the IBS-M population (Z 12.1% andP 1.8%) compared to with the IBS-C (Z 7% and P 2.4%) subset. Howeverdiscontinuations due to diarrhea were low in both subsets (1.5% for IBS-Mand 0.6% for IBS-C). Diarrhea with Zelnorm typically occurred soon afterinitiating therapy and lasted 2-3 days without recurrence. There were nocases of diarrhea with clinically significant consequences (i.e.,hospitalization, need for IV fluids, abnormal lab values). About Zelnorm Zelnorm is indicated for the treatment of men and women less than 65years of age with Chronic Idiopathic Constipation. The effectiveness ofZelnorm in patients 65 years or older with Chronic Idiopathic Constipationhas not been established. Zelnorm is also indicated for the short-termtreatment of women with IBS whose primary symptom is Constipation. Thesafety and effectiveness of Zelnorm in men with IBS with Constipation havenot been established. Efficacy beyond 12 weeks has not been studied.Zelnorm is the first in a novel class of drugs that act as an agonist at5HT4 (serotonin type 4) receptors. Zelnorm mimics the natural effects ofserotonin by activating 5HT4 receptors, which normalizes impaired motilityin the GI tract, inhibits visceral sensitivity and stimulates intestinalsecretion. Overall, safety data is now available in more than 14,000patients who have enrolled in clinical trials assessing Zelnorm's safetyand efficacy in various GI conditions. Serious consequences of diarrhea, including hypovolemia, hypotension,and syncope, have been reported with Zelnorm. Zelnorm should bediscontinued immediately in patients who develop severe diarrhea,hypotension, or syncope. Zelnorm should not be initiated in patients whoare currently experiencing or frequently experience diarrhea. Zelnorm should be discontinued immediately in patients with new orsudden worsening of abdominal pain. Ischemic colitis and other forms ofintestinal ischemia have been reported in patients receiving Zelnorm duringmarketed use of the drug. In some cases, hospitalization was required.Patients who develop symptoms of ischemic colitis such as rectal bleeding,bloody diarrhea, or new or worsening abdominal pain should discontinuetherapy immediately and be evaluated. Zelnorm should not be resumed ifischemic colitis or other forms of intestinal ischemia are diagnosed. Acausal relationship between Zelnorm and these events has not beenestablished. They only adverse events reported significantly more oftenwith Zelnorm than with placebo were diarrhea (7% vs. 3%) in ChronicConstipation studies, and headache (15% vs. 12%) and diarrhea (9% vs. 4%)in IBS with Constipation studies. Zelnorm was developed by Novartis and is also known in some countriesas Zelmac. Approximately 3 million patients worldwide have been treatedwith Zelnorm to date. It is approved in more than 56 countries for IBS withConstipation. Zelnorm also is approved for use in Chronic Constipation inmore than 20 countries, including Mexico and many of the Latin Americancountries. About DDW Digestive Disease Week (DDW) is the largest international gathering ofphysicians, researchers and academics in the fields of gastroenterology,hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored bythe American Association for the Study of Liver Diseases (AASLD), theAmerican Gastroenterological Association (AGA), the American Society forGastrointestinal Endoscopy (ASGE) and the Society for Surgery of theAlimentary Tract (SSAT), DDW takes place Sunday, May 21 through Thursday,May 25 in Los Angeles, CA. The meeting showcases approximately 5,000abstracts and hundreds of lectures on the latest advances in GI research,medicine and technology. Forward-Looking Statement This release contains certain forward-looking statements relating tothe Company's business, which can be identified by the use offorward-looking terminology such as "may," "showing promise," "potential,"or similar expressions, or by discussions of strategy, plans or intentions.Such forward- looking statements involve known and unknown risks,uncertainties and other factors that may cause actual results with Zelnormto be materially different from any future results, performance orachievements expressed or implied by such statements. Specifically, thereare no guarantees that the data described above will result in thecommercial success of Zelnorm. Any such success can be affected by, amongother things, uncertainties relating to product development, futureclinical trial results related to dyspepsia, GERD and other medicalconditions, adverse regulatory actions or delays, government regulationgenerally, the ability to obtain or maintain patent or other proprietaryintellectual property protection, competition in general and other risksand factors referred to in the Company's current Form 20-F on file with theSecurities and Exchange Commission of the United States. About Novartis Novartis Pharmaceuticals Corporation researches, develops, manufacturesand markets leading innovative prescription drugs used to treat a number ofdiseases and conditions, including those in the cardiovascular, metabolic,cancer, organ transplantation, central nervous system, dermatological,gastrointestinal and respiratory areas. The company's mission is to improvepeople's lives by pioneering novel healthcare solutions. Located in East Hanover, New Jersey, Novartis PharmaceuticalsCorporation is an affiliate of Novartis AG (NYSE: NVS) - a world leader inoffering medicines to protect health, treat disease and improve well-being.Our goal is to discover, develop and successfully market innovativeproducts to treat patients, ease suffering and enhance the quality of life.Novartis is the only company with leadership positions in both patented andgeneric pharmaceuticals. We are strengthening our medicine-based portfolio,which is focused on strategic growth platforms in innovation-drivenpharmaceuticals, high-quality and low-cost generics and leadingself-medication OTC brands. In 2005, the Group's businesses achieved netsales of USD 32.2 billion and net income of USD 6.1 billion. ApproximatelyUSD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland,Novartis Group companies employ approximately 91,000 people and operate inover 140 countries around the world. For more information, please visithttp://www.novartis.com. (1) A Prospective Assessment of Bowel Habit in Irritable Bowel Syndromein Women: De.ning an Alternator. Drossman, et. al. GastroenterologySOURCE Novartis Pharmaceuticals Corporation


----------



## ABNormal (May 24, 2006)

The statistics I have seen are that it is effective for about 60% of the patients. Unfortunately I was one of the 40%. It worked for about a week and then nothing.


----------



## vikee (Feb 5, 2000)

Hi Jeff, I like to keep my IBS on the D side because gas and D in the morning usually work for the whole day and eliminate incomplete evaucation. I feel fully empty and fine. However, to get to â€ his stage takes manipulatin with my Diet and Vitamin C etc. Whatever I use works for only a few months, then stops so I try something else or as a last resort Miralax. I switch back and forth with short times of nothing working.I have followed Zelnorm from day one and never used it cause I thought it would cause formed stools which doesn't allow me to feel empty and eliminate only once a day.Am thinking of trying Zelnorm but wonder if it interacts with other psychiatric prescription medication which I take and minor ones for minor conditions. Also I inject Avonex for my Multiple Sclerosis (do NOT suffer from MS Consipation).Are you familiar with the drug interactions or know where I could get reliable (not panicked) information?Any Help would be greatly appreciatewd.PS. Your BB has gone beyond my wildest expectations! You are helping so many people who are not understood by the Traditional Medical Establishment in many areas of the US! God Bless you for all you have done.VikeeVicki NewmanBethlehem, PA


----------



## Tiss (Aug 22, 2000)

vickee, I have taken Zelnorm for almost 3 years and never have a formed stool. It is always loose like D. So who knows, you may be someone that Zelnorm works for!


----------



## Janet Robinson (Sep 21, 2006)

I have CI took it for 3 days and was doubled over, didn't work for me.


----------



## vikee (Feb 5, 2000)

Tiss, Thanks, I may try it even though it didn't work for Janet. It all depends on any interaction with my other prescription meds. But thanks for the imput Janet. Sorry it didn't help you.


----------



## 21483 (Oct 23, 2005)

It's obviously been awhile since I've logged on but I do have IBS-M and always stopped taking the Zelnorm once it got to a D stage. So this is really interesting. Thanks for posting it.


----------



## 18894 (May 17, 2006)

I've been taking Zelnorm for about 2 months now. It was working great, but now I've started having a breakout of red bumps and I itch something awful. Do you know if that's a side effect of Zelnorm? I decided to try going without the Zelnorm and see what happens. That way at least I'll know if that's causing this problem.


----------



## vikee (Feb 5, 2000)

EJ, Thanks for the post. Do you have any allergies? It could be one of so many things or a combination of things.I have lots of allergies but mostly to inhalents. I know from experience that there are so many variables that effect our bodies it's often hard to get to the actual cause of the problem!Let us know what happens!! You might want to consider reintroducing Zelnorm at another time to see what happens, if the rash stops this time.As always be sure to check with your Doctor and let him or her know what is happening to you.


----------

