Collaboration with academia in the development of vaginal microbicides

Advanced Care Products has been active in the development of vaginal microb icides, with public sector support. Currently, nonoxynol-9 gel is being eva luated in two Phase-III studies. Work has been conducted on polystyrene sul fonate, with the aim of filing an investigational new drug application (IND ) in the USA. This paper discusses the challenges in development of an over -the-counter (OTC) product for the USA. Public sector support has been pivo tal in the progress shown to date. Further challenges lie ahead, vis-a-vis an OTC approval. (C) 1999 International Federation of Gynecology and Obstet rics.