FDA Approves New Formulation of Protease Inhibitor Viracept; Reduced Pill Burden May Increase Adherence
The FDA on Wednesday approved a new formulation of Viracept, also known as nelfinavir, which could reduce the number of pills HIV patients take each day and increase adherence to treatment regimens, according to an FDA release. Viracept, a protease inhibitor that is approved for the treatment of HIV infection in combination with other antiretroviral drugs, is available in 50 mg oral powder and 250 mg tablets. The new 625 mg formulation reduces the number of pills a patient has to take from five 250 mg tablets twice a day to two 625 mg tablets twice a day (FDA release, 4/30). "To help improve adherence, we felt a simplified dosing regimen was a critical next step for this proven therapy," Richard Ogden, senior director of scientific development for Agouron Pharmaceuticals, a Pfizer company, which developed the drug, said, adding, "The new tablets were designed for ease of use, and we hope that both new and current Viracept users will find the switch effortless" (Agouron release, 4/30). Agouron has submitted clinical data showing that the higher exposure is not dangerous; however, diarrhea may be more common in patients who take the 625 mg tablets (FDA release, 4/30).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.