Supplemental NDA filed with FDA for Osphena to add vaginal dryness to dyspareunia.- Duchesnay.

Duchesnay announced that it has submitted a supplemental New Drug Application to the FDA seeking a new indication for Osphena (ospemifene). Osphena received FDA approval for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy (VVA) due to menopause, in February 2013. The company is currently seeking FDA approval to add the indication of moderate to severe vaginal dryness, also a common symptom of vulvar and vaginal atrophy due to menopause. The action date by which FDA must complete its review of the application, as required by the Prescription Drug User Fee Act, is January 26, 2019.

This application is based on new safety and efficacy data acquired through a confirmatory phase III randomized, double blind, placebo-controlled multicenter study evaluating the efficacy and safety of ospemifene in patients with moderate to severe vaginal dryness.

Comment: Duchesnay has amassed a significant amount of data regarding ospemifene, including 10 phase 2 and 3 studies. This data has been submitted with the application and is currently under evaluation by the United States Food and Drug Administration.