MacroChem's Topiglan for ED clears Ph III trial

MacroChem's topical treatment for erectile dysfunction, Topiglan(alprostadil), has shown efficacy in a Phase III trial, despite evidence of an unexpected dec-rease in drug potency in tested samples uncovered after the study closed. Topiglan gel is applied to the head of the penis just prior to intercourse, and is positioned as an alternative to oral treatments for ED, such as Pfi-zer's Viagra (sildenafil) and injectable treatments.

While statistical significance was not achieved on all the endpoints in the study, the firm believes that the overall trend to a positive effect, along with the reduced Topiglan potency, bodes well for the future of the program. MacroChem is planning to meet with the US Food and Drug Administration to discuss the protocols for additional clinical trials using a reformulated Topiglan dispenser that should improve drug delivery.