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 Daily | VivaGel nod from FDA

VivaGel nod from FDA

Other recent headlines

RACGP slams SA move

PSA’s new vaping criteria

IPA makes room for charity

SEARCH PHARMACY DAILY

Featured video

Recent issues

INDUSTRY JOB VACANCIES