VivaGel nod from FDA

January 12, 2012

STARPHARMA has received Special Protocol Assessment approval from the US Food and Drug Administration for the design of its Phase 3 clinical studies of VivaGel for the treatment of bacterial vaginosis. Under the Special Protocol Assessment scheme Starpharma’s Phase 3 clinical study design, endpoints, statistical analysis and other aspects of the planned studies are acceptable to support regulatory approval for the product. According to Starpharma the VivaGel is “a gel-based formulation of a nano-pharmaceutical under development as a vaginal microbicide to prevent the transmission of sexually transmitted infections including HIV and genital herpes; and also for the treatment and prevention of bacterial vaginosis”.

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Pharmacy DailyPharmacy Daily | VivaGel nod from FDA

VivaGel nod from FDA

Other recent headlines

Prescribing endorsement consultation opens

Call for embedded rural pharmacist pilot

MTick: Behind the menopause ‘one-stop shop’

SEARCH PHARMACY DAILY

Featured video

Recent issues

INDUSTRY JOB VACANCIES