FDA provides complete response letter for Vitaros in erectile dysfunction.- Apricus Biosciences.

Apricus Biosciences announced that the FDA has issued a complete response letter for the New Drug Application (NDA) of Vitaros (alprostadil, DDAIP.HCl), a topical cream for the treatment of erectile dysfunction. The CRL indicates that the FDA cannot approve the NDA for Vitaros in its present form, identifying deficiencies related to Chemistry, Manufacturing and Control and certain safety concerns specific to the 2.5% concentration of DDAIP.HCl contained in the current formulation.

Comment: this new potential entrant into the U.S. ED treatment market has been approved in Canada, Mexico and certain countries in Europe, Latin America and the Middle East and the product is being commercialized by Ferring International Center S.A. and its licensees throughout Europe and in the Middle East.