SAN DIEGO, July 23, 2013 /PRNewswire/ -- Evofem is pleased to announce the early completion of enrollment for their 3,200-subject Phase III registration study of Amphora® non-hormonal contraceptive gel.
The global trial compares Amphora to Conceptrol®, the brand name of Nonoxynol-9, and the only spermicidal gel currently approved by the FDA.
"We are very pleased with the progress on the development of Amphora," said Tommy G. Thompson, former US Health and Human Services Secretary and Chairman of the Evofem Board of Directors. "Evofem is committed to providing women around the world with greater contraceptive choice and we expect Amphora to fill a critical gap in the market as an inexpensive, easy-to-use product that is woman-controlled and used only when necessary, on-demand."
The Amphora clinical trial is being conducted by Health Decisions, a leading clinical research organization (CRO). "We are delighted that we could accelerate development of Evofem's Amphora contraceptive," said Health Decisions CEO Michael Rosenberg, MD, MPH. "The same award-winning technology that we used in this study has enabled us to help many other sponsors bring drugs and medical devices to market ahead of projections."
Evofem LLC is a privately held biotechnology company that brings advanced prescription and consumer products to global markets. Through its subsidiaries, Evofem Inc. and Cosmederm Bioscience, Evofem discovers, develops and commercializes prescription and over-the-counter products, in the areas of dermatology, pain management, feminine care, contraception, and the prevention of sexually transmitted infections. In February 2013, Evofem entered into a strategic alliance with WomanCare Global, a nonprofit organization whose mission is to provide access to quality, affordable, women's healthcare products through a sustainable supply chain in over 100 countries, with a particular focus on under-served markets in Africa, Asia, and Latin America. Through this alliance, WomanCare Global provides sales, marketing and global distribution support to Evofem's products.