TherapeuticsMD, Inc. received a letter from the U.S. Food and Drug Administration asking the company to submit more safety data for its drug TX-004HR.
The new drug application for TX-004HR, a potential treatment for moderate-to-severe vaginal pain during sexual intercourse, was rejected by the FDA in May for lack of long-term safety data. The company submitted certain additional safety data on July 5.
In its recent letter, the FDA asked the company for some more information, including safety results from a specific large unpublished study of long-term users of vaginal estrogens. The response must be submitted on or before Sep. 18, following which the FDA will meet with the company on Nov. 3 to discuss the outcome of its review.
The company said it plans to resubmit its new drug application shortly after meeting with the FDA in November.