The U.S. Food and Drug Administration (FDA) has declined the New Drug Application (NDA) for TX-004HR from TherapeuticsMD Inc (NYSEMKT:TXMD). The Women’s healthcare company says that the rejection was on the basis of issues related to long-term safety data. Apparently, the investigational applicator-free estradiol vaginal softgel capsule did not have any concerns related to efficacy.
However, the agency still refused to give an approval for the treatment of moderate-to-severe vaginal pain during sexual intercourse. Despite having pointed out the reason for rejection, the complete response letter (CRL) issued by the FDA did not question the chemistry, manufacturing, and controls of the drug. It is for this reason that Robert Finizio, TherapeuticsMD’s Chief Executive cites their disagreement with the FDA’s decision of non-endorsement.
TherapeuticsMD believes that the NDA was approvable
There are a lot of questions regarding how the FDA arrived at its decision because, in the 12 weeks trial of TX-004HR, no cases of endometrial hyperplasia were observed. As such the healthcare company still emphasizes that the NDA was approvable. In this regard, the company intends to meet with the FDA to address the matter.
Meanwhile, Finizio notes, “While we are disappointed that the NDA for TX-004HR was not approved at this time…we believe there are multiple paths forward to address the concerns raised by the FDA.”
The development of exclusive products for women
TherapeuticsMD has been in the front lines of developing feminine products such that despite the disappointment, it has vowed to remain committed in the development of advanced hormone therapy pharmaceutical products.
The Boca Raton, Florida-based company is also involved in the manufacturing and distribution of branded and generic prescription prenatal vitamins. It is currently working on a late-stage clinical pipeline of two phase 3 product candidates; moderate-to-severe vasomotor symptoms (VMS) during the menopause and moderate-to-severe vaginal pain during sexual intercourse.
Meanwhile, TherapeuticsMD’s stock was trading at $4.18 a fall of $0.49 or 10.49%.