FDA Rejects TherapeuticsMD NDA for Sex Pain Drug

FDA has sent TherapeuticsMD a complete response letter (CRL) on its NDA for TX-004HR, an investigational applicator-free estradiol vaginal softgel capsule for treating moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy due to menopause. The agency’s letter raised concern about a lack of long-term endometrial safety data beyond the 12-weeks studied in the pivotal phase 3 Rejoice Trial, the company says. “No cases of endometrial hyperplasia were observed in the Rejoice Trial at the end of week 12 for all the doses studied and included in the NDA,” it says. “The CRL did not identify any issues related to the efficacy of TX-004HR and did not identify any approvability issues related to chemistry, manufacturing, and controls. The company believes that the NDA was approvable as filed and intends to meet with the FDA as soon as possible to address the concerns raised by the FDA.”