ContraVir Pharmaceuticals, Inc. (OTCBB: CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that it has been granted a Type B meeting with the U.S. Food and Drug Administration (FDA) to discuss its proposal for the design of a Phase 3 trial of ContraVir's lead antiviral candidate, FV-100. The meeting will take place in the first quarter of 2015 and will focus on evaluating both completed and planned FV-100 clinical studies, including the proposed upcoming Phase 3 trial of FV-100 to prevent the debilitating shingles-associated pain known as post-herpetic neuralgia (PHN).
While antivirals are approved to treat the viral infection underlying shingles, there are currently no approved antiviral therapies for preventing PHN. It remains a major unmet medical need, and ContraVir has been exploring the potential of FV-100 to prevent the severe and long-lasting effects of this condition.
"ContraVir is well positioned to capture the growing demand for PHN treatments, and we are confident in our current clinical plan for FV-100," said James Sapirstein, Chief Executive Officer of ContraVir. "We requested this meeting with the FDA to help us define primary outcomes and analyses, which will form the foundation of our registration package."
ContraVir Pharmaceuticals, Inc.