FDA panel recommendation: Zelnorm considered as constipation Tx.(News)

ROCKVILLE, MD. -- A federal advisory panel has recommended approval of the irritable bowel syndrome drug tegaserod as a treatment for primary chronic constipation in women under age 65.

At a meeting of the Food and Drug Administration's gastrointestinal drugs advisory panel, 10 of the 13 panel members supported approval of the 5-H[T.sub.4] receptor partial agonist for this indication. Most agreed that the approval should be limited to women, who made up 90% of the participants in clinical trials of the drug, which is marketed under the trade name Zelnorm by Novartis. Still, several panelists said that men should not be denied the drug.

The panel unanimously voted against recommending approval of an unrestricted indication that had been proposed by Novartis: treatment of "chronic constipation and relief of the associated symptoms of straining, hard or lumpy stools, and infrequent defecation." Instead, the panel supported use of the drug in patients with chronic idiopathic or functional constipation, not for constipation that is drug-induced, or caused by metabolic factors or comorbid conditions.

Tegaserod was approved in 2002 for treating women with the constipation-predominant form of irritable bowel syndrome.

Panelists agreed that the data on people aged 65 and older, who made up 9%-16% of subjects in the two pivotal chronic constipation trials, were not adequate to support the drug's use for chronic constipation in the elderly, citing concerns about the serious implications of diarrhea in this age group and the insignificant effect of the drug in patients 65 and older.

Some panelists also recommended limiting treatment to a 12 week course of therapy, which was the duration of treatment in the trials.

But three panelists, all gastroenterologists, voted against approval, including Dr. Alan Buchman of Northwestern University. Chicago, who voted against approval "under any circumstances." He said that although there was a suggestion of efficacy in the tegaserod trials, it was "not sufficient for me to waive the adverse events" in favor of approval.