The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the New Drug Application (NDA) of TX-004HR (TherapeuticsMD) for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause.

The FDA raised a concern regarding the lack of long-term endometrial safety data for TX-004HR beyond the 12-weeks studied in the Phase 3 Rejoice Trial. The NDA included results from this pivotal trial, showing that no cases of endometrial hyperplasia were observed at the end of Week 12 for all doses of TX-004HR. No approvability concerns related to efficacy, chemistry, manufacturing, and controls were identified in the CRL. 

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TherapeuticsMD intends to meet with the FDA as soon as possible to address the concerns raised by the agency.

TX-004HR is an investigational applicator-free estradiol vaginal softgel capsule.

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