Posted by Michael Wonder on 30 Jan 2019
Duchesnay receives approval of supplemental new drug application to add moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy due to menopause, to the indication of Osphena (ospemifene)
29 January 2019 - Duchesnay announced today that the FDA has approved its supplemental new drug application seeking to add moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy (VVA), due to menopause, to the indication of Osphena (ospemifene).
The application was based on new safety and efficacy data acquired through a confirmatory phase 3 randomized, double blind, placebo-controlled multicenter study evaluating the efficacy and safety of ospemifene in patients with moderate to severe vaginal dryness. Osphena is non-hormonal and helps improve specific vaginal tissues by increasing superficial cells, decreasing parabasal cells and reducing vaginal pH.
Prior to this approval, Osphena was indicated only for the treatment of moderate to severe dyspareunia (painful intercourse), also a symptom of VVA, due to menopause.
