US FDA approves Novartis' Zelnorm for constipation-predominant IBS in women

Novartis' Zelnorm (tegaserod maleate) has become the first and onlyprescription drug approved by the US Food and Drug Administration for the short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation. The drug had previously been rejected by the agency on safety grounds, but pressure from patient groups caused it to reverse its earlier decision (Marketletter June 11 and 25, 2001).

In granting this approval, the company notes, the medical community has recognized that therapies traditionally used to treat these symptoms of IBS have been generally ineffective or poorly tolerated.

Zelnorm is the first agent in a new class of drugs, serotonin-4 receptor agonists (5HT4 agonists), developed to target the gastrointestinal tract. By activating the 5HT4 receptors, the drug stimulates the peristaltic reflex and normalizes impaired motility in the GI tract.