Zelmac (Tegaserod) New Drug Application Filed for the Treatment of Irritable Bowel Syndrome home_chicklet1.gif [1/3]

From: Helen Dynda (olddad66@runestone.net)
Mon Mar 20 20:08:48 2000

From: "Helen Dynda" <olddad66@runestone.net> To: <adhesions@obgyn.net> Subject: Zelmac (Tegaserod) New Drug Application Filed for the Treatment of Irritable Bowel Syndrome Date: Mon, 20 Mar 2000 21:09:25 -0600 MIME-Version: 1.0 Content-Type: multipart/related; type="multipart/alternative"; boundary="----=_NextPart_000_0015_01BF92B0.958B58A0" X-Priority: 3 X-MSMail-Priority: Normal X-Mailer: Microsoft Outlook Express 5.00.2919.6600 X-MimeOLE: Produced By Microsoft MimeOLE V5.00.2919.6600

Zelmac (Tegaserod) New Drug Application Filed for the Treatment of Irritable Bowel Syndrome - Drugs in the News - Pharmacology and Legal Drugs - From About.com You are here: About.com > Health/Fitness > Pharmacology > Guide Extra

Mon, Mar 20, 2000

Mary Ann Elchisak - your About.com Guide to: Pharmacology

-------------------------------------------------------------- =20 -------------------------------------------------------------- Content: Welcome | Netlinks | Articles | Guide Bio | =

Search | Related
                  TalkAbout: Forums | Chat | Events | Newsletter | Share This Site | Join
                  Shopping: ShopNow | Books | Videos | Jobs | ShoppingAbout

-------------------------------------------------------------- =20 -------------------------------------------------------------- Search this GuideSite about "+zelmac" =20 -------------------------------------------------------------- Zelmac™ (Tegaserod) New Drug Application Filed for the Treatment of Irritable Bowel Syndrome 02/16/2000

| Press Release | How To Find Drug Info | Search This Site | Questions or Comments? Post Them in the Forum!

Press Release: East Hanover, New Jersey, February 16, 2000 - Novartis Pharmaceuticals Corporation today announced that it has submitted a new drug application (NDA) to the US Food and Drug Administration for Zelmac™ (tegaserod) tablets, an innovative treatment for the multiple symptoms of irritable bowel syndrome (IBS). A regulatory submission was also filed with the European Medicines Evaluation Agency (EMEA).

Phase III studies have demonstrated that within the first week after starting treatment, Zelmac therapy provided statistically significant relief of IBS symptoms in patients who suffered primarily from abdominal pain and constipation.

“Zelmac offers an entirely new approach to treat the multiple symptoms of irritable bowel syndrome, a debilitating disorder of GI function that involves altered motility and an increase in pain perception,” said Marvin M. Schuster, M.D., Professor of Medicine, Johns Hopkins University of Medicine, Baltimore, MD. “Lack of satisfactory therapies for IBS has been frustrating for both physicians and patients. Zelmac could provide a valuable new option since it improves motility and may reduce pain perception.”

IBS is one of the most common disorders of function of the gastrointestinal (GI) tract, affecting up to 20 percent of the Western population.1 It is a chronic condition characterized by abdominal pain, bloating, and symptoms associated with irregular bowel function, such as constipation, diarrhea or an alternating pattern between the two. IBS is the second most common cause of work-related absenteeism in the US.2,3 It accounts for one in four GI visits and costs the US healthcare system $8 billion annually.4,5 To date, no medication has proven to be safe and effective in treating IBS patients who suffer from abdominal pain, constipation and bloating as their primary symptoms.

“While all IBS sufferers experience pain, it is important to understand that the majority of patients also have constipation as a primary symptom,” said Dr. Schuster. “The prevalence of constipation makes the potential availability of Zelmac attractive for treating the multiple symptoms of IBS patients.”

Study Results The filing submitted to the regulatory authorities includes data from three phase III clinical studies of Zelmac, involving more than 2,500 patients in 15 countries.

Two multicenter, double-blind, placebo-controlled studies of similar design involving 1,680 patients found those treated with Zelmac showed clinically relevant and statistically significant relief of symptoms as measured by the Subject’s Global Assessment (SGA) of relief. SGA of relief is a global assessment that incorporates symptoms of abdominal pain, overall well being and altered bowel function. Significant improvement of symptoms was demonstrated within the first week and was sustained over the course of the 12-week treatment period.

Specific effects of Zelmac on IBS symptoms were also assessed through analysis of a daily diary kept by the patients. Zelmac was found to significantly reduce abdominal pain in both studies and bloating in one study. Additionally, Zelmac increased the number of bowel movements per day and reduced the number of days with no bowel movements. Zelmac also improved bowel function as early as day one.

Safety and Tolerability Zelmac was found to be well tolerated with side effects comparable to placebo. Diarrhea was the predominant adverse event reported more often in Zelmac treatment groups (12% on Zelmac vs. 5% on placebo). In most cases, the diarrhea occurred early, was transient, and resolved with continued therapy. Only 1.6% of patients discontinued Zelmac therapy due to diarrhea. A long-term study of IBS patients treated up to 12 months, reported a similar safety and tolerability profile.

About Zelmac Zelmac belongs to a new chemical class of compounds which selectively target and act on 5-HT4 receptors present throughout the GI tract. These serotonin receptors are believed to play a key role in pain perception and GI motility. By acting on the 5-HT4 receptor pathway, Zelmac reduces abdominal pain and may normalize altered GI function in IBS patients who suffer from abdominal pain, constipation and bloating as their predominant symptoms.

Other Potential Indications Novartis is currently conducting clinical trials studying Zelmac as a potential treatment for gastroesophageal reflux disease (GERD).

“Zelmac is designed to tackle one of the most common digestive tract disorders,” said A. N. Karabelas, CEO Novartis Pharma AG. “It may offer significant benefits to IBS patients and could help address one of the leading causes of lost days from work. The filing also represents an important milestone for Novartis as it enters the gastrointestinal therapeutic market.”

Novartis Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The company's mission is to improve people's lives by pioneering novel healthcare solutions.

Located in East Hanover, Novartis Pharmaceuticals Corporation is an affiliate of the Novartis Group, a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 1998, the Group (including Agribusiness) achieved sales of USD 21.8 billion and invested more than USD 2.6 billion in R&D. Headquartered in Basel, Switzerland, Novartis employs about 82,000 people and operates in over 140 countries around the world. The Group recently announced plans to spin off its Crop Protection and Seeds sectors and to merge them with the agrochemicals business of AstraZeneca in the second half of 2000.

References 1 Weber, FH and McAllum, RW. Clinical approaches to irritable bowel syndrome. Lancet. Vol 340: December 12, 1992, p. 1447-1451. 2 Weber, p. 1447. 3 Schuster, M. Diagnostic evaluation of the irritable bowel syndrome. Gastroenterology Clinics of North America. Vol. 20, No. 2, June 1991. 4 American Gastroenterological Association Medical Position Statement: Irritable Bowel Syndrome, November 1996. 5 Talley, J. Medical costs in community subjects with irritable bowel syndrome. Gastroenterology. 1995; 109: 1736-1741.

SOURCE: Novartis Pharmaceuticals

Information and links in this press release were accurate as of the date posted near the beginning of the release. You can search this site or check New Drug Approvals or Drugs in the News for updates or more recent information.

Return to top


For more information or details concerning specific drugs or = -------------------------------------------------------------------- topics, try searching this web site. If you still need more info = -------------------------------------------------------------------- concerning individual drugs, it can usually be obtained by following the tips listed on our How To Find Drug Info page. Drug Manufacturer's Web Sites are also a good source, especially for newer drugs when other information is less readily available. If you've tried and still can't find the info you need, try posting your question in the Pharmacology Forum. I personally reply to some questions posted in the forum, but if you have a particular interest or expertise, please, feel free to reply to questions or add your comments or opinions. I regret that I can't answer email questions, although your comments are always welcome. The Contact Information and FAQs Page is also always available.

How To Find Drug Info

Drug Manufacturer's Web Sites

New Drug Approvals Index

Drugs in the News Index

Featured Articles

Return to top

produced/revised/updated: 2000-02-17 05:14 PM

Related About.com GuideSites a.. Anesthesiology

b.. Family Medicine

c.. Internal Medicine d.. Neurosciences

e.. Substance Abuse

f.. Surgery

Elsewhere on About.com What's New, What's Hot

g.. Breaking News

h.. Viagra: Fertility Drug, Too?

i.. Why America Has More Trees JustAbout

j.. Quit Smoking

k.. Healthy Living

l.. Twisted Travel

-------------------------------------------------------------- Search=20 -------------------------------------------------------------- =20 -------------------------------------------------------------- This Site About.com -------------------------------------------------------------- =20 -------------------------------------------------------------- Share This Site With a Friend (enter their email = -------------------------------------------------------------- address below):

Top of Page

OnHealth News

Staying Fertile

What's the Deal With the Rest of Your Brain?

Making the Most of Bad Air Days

More News

BleedingBurnsDrowningEarsEyesFaintingFrostbiteHeadHemorrage JointsNosebleedPoisioningShockSnakebiteSunstroke

Important Disclaimer Information about this About.com Site

© 2000 About.com, Inc. All rights reserved. © 2000 About.com, Inc. "MiningCo.com" and "About.com" are trademarks of About.com, Inc., a publicly traded company listed on NASDAQ under the symbol "BOUT." For more information on About.com, visit Our Story, Be a Guide, Be an Advertiser, or Investor Relations. For rules of use, read our User Agreement; for privacy concerns, read our Privacy Policy. Having a Problem? Report it here.

Enter keywords:
Returns per screen: Require all keywords: