FDA approves Zelnorm for IBS with constipation.(irritable bowel syndrome)(Brief Article)

2002 SEP 5 - (NewsRx.com & NewsRx.net) -- The Novartis drug Zelnorm (tegaserod maleate) has become the first and only prescription medication approved by the U.S. Food and Drug Administration (FDA) for the short-term treatment of women with irritable bowel syndrome (IBS) whose primary bowel symptom is constipation.

Until now, no prescription medication has been approved in the United States to treat the multiple symptoms of abdominal pain and discomfort, bloating, and constipation associated with IBS. The medical community has recognized that therapies traditionally used to treat these symptoms have been generally ineffective or poorly tolerated.

"Zelnorm marks a breakthrough for the millions of women who have suffered for years with IBS with constipation waiting for a safe and effective therapy to relieve their symptoms," said Daniel Vasella, MD, chairman and CEO, Novartis AG. "As with our discoveries in oncology, heart disease, and transplantation, Zelnorm reflects our commitment to bring innovative treatments to patients with significant unmet needs. We will rapidly make Zelnorm available to patients, and plan for an early fall market introduction."

IBS is characterized by abdominal pain and discomfort, bloating, and altered bowel function (constipation and/or diarrhea). IBS affects up to one in five Americans. Second only to the common cold as a leading cause of workplace absenteeism in the U.S., IBS costs the U.S. healthcare system up to an estimated $30 billion annually in direct and indirect costs.

"Patients suffering from abdominal pain, bloating, and constipation associated with IBS endure a great deal of distress, often preventing them from participating in such simple everyday activities as going to work or school, participating in sports, or enjoying a vacation with their family," said Nancy Norton, president and founder of the International Foundation for Functional Gastrointestinal Disorders. "The approval of Zelnorm is very exciting news for millions of women who suffer from this condition."

Until recently, the cause of IBS has been poorly understood and under appreciated. However, in recent years, new research has yielded a better understanding of IBS and its causes. People who have abdominal pain and discomfort, bloating, and constipation associated with IBS have a lower GI tract that may be more sensitive and work more slowly than it should. This may be due to the way their lower GI tract reacts to changes in a naturally occurring chemical in their body ...