FDA Accepts TherapeuticsMD NDA for Yuvvexy

FDA has accepted for review a TherapeuticsMD NDA for Yuvvexy, an investigational bio-identical 17β-estradiol vaginal softgel capsule for treating moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy in postmenopausal women. The agency has set a user fee review target date of 5/7/2017.

The 505(b)(2) NDA is supported by data from the Yuvvexy clinical program, including results from the Phase 3 Rejoice Trial, which evaluated the effect of three doses of Yuvvexy (4 mcg, 10 mcg and 25 mcg) compared to placebo from baseline to week 12. The results, according to the company, demonstrated statistically significant and clinically meaningful improvements in dyspareunia, a co-primary endpoint, and vaginal dryness, a secondary endpoint. Statistically significant results were seen as early as two weeks after treatment began.