TherapeuticsMD (NSDQ:TXMD) shares fell 7% yesterday after the company announced that the FDA accepted its resubmitted application for TX-004HR, an investigational, applicator-free estradiol vaginal soft-gel capsule for the treatment of dyspareunia.
The company’s shares took a hit presumably because it revealed that its resubmitted application is a Class 2 response – a Class 1 response would have quickened the timeline for potential approval. As a Class 2 response, the FDA is slated to make a decision in six months.
TherapeuticsMD’s product is designed to treat moderate-to-severe vaginal pain experienced during sex, a symptom of vulvar and vaginal atrophy in women who have undergone menopause.
The company received a complete response letter from the FDA for its first application in May this year. The company submitted additional endometrial safety data to the FDA in September, which the FDA said was outside an official review cycle and ultimately caused the agency to designate the resubmitted NDA a Class 2 response.
“The acceptance of the NDA resubmission for TX-004HR is an important milestone for TherapeuticsMD and this PDUFA target action date will allow us to maintain our timelines for launch as early as July 2018,” TherapeuticsMD CEO Robert Finizio said in prepared remarks. “If approved, TX-004HR has the potential to be a highly differentiated treatment option for the 32 million postmenopausal women in the United States who suffer from symptoms of VVA.”