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U.S. Department of Health and Human Services

For Consumers

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FDA approves new, alternate dosing formulation of Viracept

4/30/2003

Today, April 30, 2003, the Food and Drug Administration approved a new alternate dosing formulation of Viracept (nelfinavir mesylate). Viracept has been available in 50 mg oral powder and 250 mg tablets. The new formulation of 625 mg reduces the pill burden from five-250 mg tablets twice a day to two-625 mg tablets twice a day, potentially facilitating adherence to treatment regimens.

Viracept is a protease inhibitor indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents. The 250-mg tablet and oral powder received marketing approval in 1997 based on substantive evidence of efficacy and safety. Results of the bioequivalence study of the 250-mg tablet and the 625-mg tablet revealed increased bioavailability with the 625-mg formulation.

The sponsor, Agouron Pharmaceuticals, has submitted clinical safety and pharmacokinetic data to FDA providing evidence that the higher exposures do not pose a safety risk. However, diarrhea may be more common in patients receiving the 625 mg formulation. No efficacy information is contained in this submission because it is unlikely that a more bioavailable formulation would be less efficacious.

The efficacy of Viracept was previously demonstrated and reviewed in NDAs 20778/9.

Richard Klein
Office of Special Health Issues
Food and Drug Administration