Novartis Pharma AG announced that Zelnorm (tegaserod maleate) was recommended for approval for the treatment of chronic constipation (CC) by the Gastrointestinal Drugs Advisory Committee to the US FDA. The Committee's recommendation was subject to specific labelling regarding age and gender. Novartis will work with the FDA to address the issues raised by the Committee.

The sNDA is supported by data from the two largest randomized, double-blind, placebo-controlled, multi-national phase III clinical trials ever conducted in the treatment of chronic constipation in more than 2,600 male and female patients. One of the studies included a 13-month extension safety study of nearly 842 patients. Zelnorm was found to significantly increase the frequency of complete spontaneous bowel movements as well as relief of the multiple symptoms patients complain about most -straining, hard stool, incomplete evacuation and infrequent defecation, the company release says.

"We are pleased the Advisory Committee has recognized Zelnorm's ability to address the needs of chronic constipation sufferers," said Bo Joelsson, VP, Global Head, Gastroenterology Therapeutic Area, Clinical Development of Novartis Pharmaceuticals Corporation. He added, "We look forward to working with the FDA on label discussions to secure approval for Zelnorm for the treatment of CC, so this novel therapy can be made available to patients at the earliest possible opportunity."

Zelnorm was approved by the FDA in July 2002 as the first and only prescription medication for the short-term treatment of women with irritable bowel syndrome whose primary bowel symptom is constipation.

The studies demonstrated that Zelnorm-treated patients experienced significantly more complete spontaneous bowel movements (CSBMs) than patients on placebo during 12 weeks. Zelnorm demonstrated early onset of action, with the majority of the Zelnorm-treated patients experiencing a spontaneous bowel movement within the first 24 hours. The response rate for the first four weeks of treatment (primary efficacy variable) was 42 per cent in the group receiving 6 mg twice a day of Zelnorm - significantly higher than the 26 percent in the placebo group (p < 0.0001). Over the 12-week period, the response rate for the 6 mg twice-a-day treated group continued to be significantly superior to placebo (44 per cent vs. 29 per cent), the release says.

Significant weekly improvements were observed in Zelnorm-treated patients for stool frequency, consistency and straining compared to placebo. Zelnorm-treated patients also reported less bothersome constipation, abdominal pain/discomfort and bloating/distension. In addition, satisfaction with bowel habits significantly improved with Zelnorm compared to placebo.

Constipation affects nearly 18 per cent of the population, or 37 million people, with more than 4.5 million Americans saying they are constipated most of the time.

Zelnorm, developed by Novartis, also known in some countries as Zelmac. Zelnorm is being studied as a potential treatment for other important GI disorders, including gastroesophageal reflux disease (GERD) and dyspepsia.