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| |  FDA Advisory Panel Recommends Lotronex For IBS Symptoms WASHINGTON, DC -- November 17, 1999 -- The investigational drug Lotronex(TM) (alosetron hydrochloride), the first of a new generation of agents being studied specifically for the treatment of multiple symptoms of irritable bowel syndrome (IBS), was recommended for approval today by a unanimous vote of the Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee.
The committee recommended Lotronex for use in women with IBS for whom diarrhea is a predominant symptom. While the favorable recommendation of the Advisory Committee is not binding, the FDA generally follows the advice of its expert panel members. The advisory committee's action followed daylong discussions that focused primarily on data from phase III trials in which Lotronex -- a potent and selective 5-HT3 antagonist -- was studied in non-constipated adult females with IBS. The medication appeared to relieve IBS pain and discomfort while improving bowel function. The neurotransmitter serotonin and 5-HT3 receptors that are extensively distributed on enteric neurons in the human gastrointestinal tract (as well as other peripheral and central locations) are thought to play a role in increasing the sensation of pain and affecting bowel function in patients with IBS. While the precise mechanism of action of Lotronex is not yet fully understood, one hypothesis is that Lotronex blocks the action of serotonin at 5-HT3 receptor sites in the enteric nervous system. IBS is a medical disorder that is estimated to affect as many as 20 percent of all adults in the U.S. with women sufferers outnumbering male sufferers by an estimated three to one. IBS is the most common gastrointestinal diagnosis among gastroenterology practices in the U.S. and is one of the top ten most frequently diagnosed conditions among U.S. physicians. The disorder is characterized by multiple symptoms that include chronic, recurrent abdominal pain and discomfort, and irregular bowel function such as diarrhea, constipation, or alternating diarrhea and constipation. "Today's recommendation by the Advisory Committee is good news for millions of American women suffering from IBS," said Nancy Norton, president and founder of the International Foundation for Functional Gastrointestinal Disorders. "It appears we are nearing a new era in the management of IBS." The two pivotal phase III clinical trials discussed at the hearing showed that treatment with Lotronex (1 mg bid for 12 weeks) was shown to be superior to placebo in providing relief of IBS pain and discomfort, decreasing urgency and reducing stool frequency in non-constipated females with IBS. Relief of IBS pain and discomfort occurred by the end of the second week of treatment in one study and by the fourth week of treatment in the second study. Once significant improvement was achieved it continued throughout the 12-week treatment period. By one week following discontinuation of Lotronex, this effect rapidly dissipated. Improvements in bowel function (urgency, frequency) in both studies were seen after one week of treatment and continued throughout the 12-week treatment periods. By one week following discontinuation of Lotronex, this effect rapidly dissipated. Data from both studies suggest that Lotronex was generally well tolerated with the most commonly reported side effects consisting of constipation (28 percent with Lotronex, 5 percent with placebo), headache (9 percent with Lotronex, 10 percent with placebo), nausea (7 percent with Lotronex, 6 percent with placebo) and gastrointestinal pain and discomfort (5 percent with Lotronex, 4 percent with placebo). "The data discussed today with the committee are consistent with what I have observed in my patients who have been enrolled in trials with Lotronex," said Dr. Lin Chang, co-director, UCLA/CURE Neuroenteric Disease Program and a presenter at the meeting on behalf of Glaxo Wellcome. "The success of current therapeutic options for IBS is limited and the medications available are generally directed at treating single symptoms. Whereas Lotronex appears to treat multiple symptoms of IBS in female patients suffering from abdominal pain and diarrhea." A New Drug Application (NDA) for Lotronex was submitted to the FDA on June 30, 1999, and was filed by the agency on August 29 with a priority review designation. Products assigned for priority review by the FDA are those which appear to represent a potential therapeutic advance over existing therapies. Under priority review, Lotronex could potentially be approved by the FDA within six months of its original submission. "We are extremely pleased with the FDA Advisory Committee's decision to recommend approval for Lotronex," said George Morrow, president & CEO of Glaxo Wellcome Inc. "We believe this medication has the potential to help
Related Links: Glaxo Wellcome Inc.
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