Abstract
Advanced Care Products has been active in the development of vaginal microbicides, with public sector support. Currently, nonoxynol-9 gel is being evaluated in two Phase-III studies. Work has been conducted on polystyrene sulfonate, 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 pivotal in the progress shown to date. Further challenges lie ahead, vis-à-vis an OTC approval.
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