Investigational Estradiol for Dyspareunia Under FDA Review

The NDA submission is based on positive data from the Yuvvexy clinical program
The NDA submission is based on positive data from the Yuvvexy clinical program

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Yuvvexy (17β-estradiol; TherapeuticsMD) for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy (VVA) in postmenopausal women.

The NDA submission was based on positive data from the Yuvvexy clinical development program, including the successful completion of the Phase 3 Rejoice Trial. The study evaluated the efficacy of Yuvvexy 4mcg, 10mcg and 25mcg vs. placebo on improvement in dyspareunia, the primary endpoint, and in vaginal dryness, the secondary endpoint, from baseline to Week 12. Study findings showed that treatment with Yuvvexy demonstrated statistically significant and clinically meaningful improvements in the two endpoints, which were seen as early as 2 weeks of treatment. 

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The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 7, 2017 to make a decision on the NDA.

Yuvvexy, formerly TX-004HR, is an investigational, applicator-free, bio-identical 17β-estradiol vaginal softgel capsule.

For more information visit TherapeuticsMD.com.

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