TherapeuticsMD (NSDQ:TXMD) is negotiating with the FDA over the proposed label for its investigational, applicator-free estradiol vaginal capsule, TX-004HR, the company reported today.
The softgel capsule 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 FDA is slated to make a decision about the company’s new drug application by the end of May.
Shares in the Florida-based company tumbled in December after the FDA accepted its resubmitted application for TX-004HR. 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.
TherapeuticsMD received a complete response letter from the FDA for its first application in May last year. The company submitted additional endometrial safety data to the FDA in September, which the FDA said was outside the official review cycle and ultimately caused the agency to designate the resubmitted NDA a Class 2 response.
TXMD shares were up 2.1% in premarket activity today, trading at $5.28 apiece.
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