Novaris and FDA Begin Treatment IND for Zelnorm

According to Novartis Pharmaceuticals Corporation, the US Food and Drug Administration and Novartis have established a program, called a treatment IND, that will allow restricted access for Zelnorm so that patients with urgent need of the medication can be considered for treatment.

The program is designed to give limited access to Zelnorm to women under the age of 55 in the US "who suffer from irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC), and for whom no other treatment has provided satisfactory relief and/or patients who had satisfactory improvement of their symptoms with prior Zelnorm treatment." Requests from physicians and patients have caused the FDA and Novartis to begin the program after a marketing suspension of Zelnorm in March 2007.

Zelnorm was originally suspended by Novartis because the FDA wanted to seek more information on the drug's benefits and potential risks, says Novartis. Clinical trials had previously shown that Zelnorm may have caused an increase in the incidence of cardiovascular ischemic events in patients who were taking the drug. There was no increase in the incidence of cardiovascular ischemic events in patients who took the placebo during the clinical trials. Novartis says that "no casual relationship between Zelnorm and cardiovascular ischemic events has been demonstrated."

Novartis also says that it "has extensively studied Zelnorm and believes that this medicine provides important benefits for appropriate patients. They are currently in discussions with the FDA so that the results of the clinical trials can be better understood.