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.
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.
For more information call (800) 266-6476 or visit Therapeuticsmd.com.