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news.The US Food and Drug Administration (FDA) has approved of the Phase 3 clinical trial for VivaGel bacterial vaginosis (BV) treatment by Starpharma, following demonstration of positive data and End of Phase 2 (EOP2) Meeting.
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The FDA has proposed design of Phase 3 studies and the development program in support of a New Drug Application (NDA) for VivaGel to treat BV.
The two Phase 3 studies, each comprising 220 participants will be conducted simultaneously and the endpoint will be Clinical Cure with placebo gel as a comparator.
Starpharma CEO Jackie Fairley said the company looks forward to advancing the program rapidly to execute a commercial licence following its completion.
The company will begin the trials in early 2012 and expects to complete before year end.