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April 5, 2011

FDA Okays BI’s Once-Daily Extended-Release Viramune Tablet for HIV-1 Therapy

  • FDA has approved a once-daily tablet formulation of Boehringer Ingelheim Pharmaceuticals’ Viramune® (nevirapine) drug for treating HIV-1. Extended-release Viramune XR™ is a once-daily, 400 mg formulation of nevirapine approved for use in combination with other antiretroviral agents in adults.

    FDA clearance was based on data from the 48-week Phase III VERxVE trial, which showed that the Viramune XR formulation was as effective, safe, and tolerable as twice-daily immediate-release Viramune (200 mg) in terms of virologic response when used in combination with Truvada® in treatment-naive adult HIV-1 patients. A supporting Phase III study, TRANxITION, also showed that patients who are already being treated using immediate-release Viramune can immediately switch to Viramune XR.

    Patients who have not previously used any formulation of Viramune need to be treated with the immediate-release formulation of the drug twice daily for at least 14 days, to help reduce the incidence of developing a rash, before treatment with Viramune XR can be considered.

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