Extended Release Dapivirine Vaginal Film
The Dapivirine extended-release monthly film, being developed by the Rohan Pharmaceutics laboratory at the University of Pittsburgh School of Pharmacy and Magee-Womens Research Institute under the VALUE (Vaginal film as A Low-cost, User-administered, and Extended-release product) project, is a game-changing female-controlled product providing monthly protection against HIV infection. The film is simple, portable, discreet, applicator-free, scalable, low cost, and bioerodible, with minimal package waste. Stakeholder inputs including end-user acceptability of film platform will be sought in key populations to guide formulation optimization. Pre-clinical data will be generated to support regulatory filing of the investigational new drug (IND) product. The proposed clinical studies will generate safety, acceptability, and pharmacokinetics data in women for the dapivirine single-entity film.