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US FDA accepts TherapeuticsMD's resubmitted application for pain drug

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US FDA accepts TherapeuticsMD's resubmitted application for pain drug

The U.S. Food and Drug Administration accepted the new drug application resubmission for TherapeuticsMD Inc.'s TX-004HR.

The drug is meant to treat moderate-to-severe vaginal pain during sexual intercourse, or dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause.

The resubmission includes the 4 mcg and 10 mcg doses of TX-004HR.

According to the company, the FDA acknowledged the resubmission as a complete, class 2 response to the complete response letter received on May 5 for the drug.

The FDA's review is expected to be completed May 29, 2018.

In addition, the agency has informed the company that the additional endometrial safety information submitted to the new drug application for TX-004HR was outside of an official review cycle, thus procedurally designating a class 2 response.

TherapeuticsMD plans to launch TX-004HR in the third quarter of 2018, if approval occurs on or before the expected completion date of the FDA review.

The resubmission is supported by a TX-004HR clinical program, including positive results of the phase 3 trial, which showed statistically significant and clinically meaningful improvements in dyspareunia.