Zelnorm to re-enter market through restricted access program
The FDA has agreed to permit limited use of Novartis' Zelnorm (tegaserod maleate) by some patients through a restricted access program, following the drug's voluntary withdrawal over cardiovascular safety concerns earlier this year.
Under the restricted access “investigational new drug protocol” program, Zelnorm may now be prescribed to women under age 55 who suffer from irritable bowel syndrome with constipation or chronic idiopathic constipation and for whom no other treatment has provided satisfactory relief, Novartis said.
Also, women who had improvement of their symptoms with prior Zelnorm treatment may receive the drug.
In addition to the age and gender restrictions, patients must sign consent materials to ensure they are fully informed of the potential risks and benefits of Zelnorm.
In March, Novartis suspended its US marketing and sales of Zelnorm after a safety analysis found a higher chance of heart attack, stroke, and heart and/or chest pain in patients treated with Zelnorm compared with treatment with a placebo.
Prior to its withdrawal, Zelnorm sales reached $561 million in 2006, with $488 million of that generated in the US.
The FDA first approved Zelnorm in 2002.