TherapeuticsMD to resubmit NDA for rebuffed vaginal pain candidate TX-004HR

After a Nov. 3 meeting with FDA, TherapeuticsMD Inc. (NYSE-M:TXMD) said the agency will not require the company to conduct an additional safety study before resubmitting an NDA for TX-004HR to treat moderate to severe vaginal pain during sexual intercourse associated with vulvar vaginal atrophy due to menopause. TherapeuticsMD said it plans to submit the NDA within the coming weeks.

In May, TherapeuticsMD said FDA issued a complete response letter for TX-004HR that cited a lack of long-term endometrial safety data beyond the 12-week Phase III Rejoice trial. In September, the company submitted to FDA a review of medical literature on the use of vaginal estrogen products, including information on the risk of endometrial hyperplasia or cancer (see BioCentury, May 11)...