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FDA Approves Film-Coated Viracept (Nelfinavir Mesylate) For HIV LA JOLLA, CA -- March 6, 2000 -- Agouron Pharmaceuticals, Inc. announced that the Food and Drug Administration (FDA) has approved a film-coated version of Viracept(R) (nelfinavir mesylate) Tablets. This new formulation is part of Agouron's continuous efforts to meet the needs of patients with HIV infection who are being treated with Viracept as part of their combination antiretroviral regimens. The film-coated version of Viracept is intended to preserve tablet integrity, and thereby may diminish the possibility of tablets dissolving prematurely and tablet breakage. The dosage strength will remain the same. "We are pleased that the FDA has approved the film-coated version of Viracept," said Kent Snyder, President, Global Commercial Operations. "For the long-term management of HIV, it is essential that treatment be made as simple and easy as possible for patients, to support adherence over time. Along with the recently approved twice-daily (BID) dosing schedule for Viracept, this new formulation will further enhance the utility of the most extensively prescribed HIV protease inhibitor in the United States." Viracept in combination with other antiretroviral agents is indicated for the treatment of HIV infection when antiretroviral therapy is warranted. This indication is based on analyses of surrogate marker changes in patients who received Viracept in combination with nucleoside analogs or alone for up to 48 weeks. At present, there are no results from controlled trials evaluating the effect of therapy with Viracept on clinical progression of HIV infection, such as survival or the incidence of opportunistic infections. Viracept is generally well-tolerated when taken 1250 mg BID or 750 mg TID. In study 542, diarrhea of moderate or greater intensity occurred in 14 percent to 18 percent of patients receiving Viracept 1250 mg BID or 750 mg TID with stavudine or lamivudine. New onset or exacerbation of diabetes mellitus and hyperglycemia, changes in the distribution of body fat, and increased bleeding in patients with hemophilia types A and B have been reported with protease inhibitors. Agouron Pharmaceuticals, Inc., a wholly owned subsidiary of the Warner-Lambert Company is an integrated pharmaceutical company committed to the discovery, development, manufacturing, and marketing of innovative therapeutic products engineered to inactivate proteins that play key roles in cancer, AIDS, and other serious diseases. Agouron employs more than 1200 people of whom approximately 800 are engaged in research and development. Related Links: Viracept (nelfinavir mesylate), Agouron Pharmaceuticals, Inc. and Warner-Lambert Company. E-mail this page to a friend or colleague! To print, use this version