TherapeuticsMD Inc (NASDAQ:TXMD) Reveals It Has Resubmitted Its New Drug Application For TX-004HR


TherapeuticsMD Inc (NASDAQ:TXMD) announced yesterday that it resubmitted its New Drug Application (NDA) For TX-004HR with the Food and Drug Administration (FDA).

The company has been developing the TX-004HR treatment as an estradiol vaginal softgel capsule that can be used to treat dyspareunia which refers to severe vaginal pain during coitus. This condition is common especially as women approach menopause.  TherapeuticsMD expects the FDA to report on whether it has accepted the resubmission of the NDA within 30 days.

The NDA resubmission will be classified by the FDA as Class 1 or Class 2 once it is accepted. Submissions that are categorized under class 1 category are reviewed within a period of two months while those in the Class 2 category are reviewed within a period of six months once the resubmission is accepted. A class 1 category for TX-004HR would thus be great news for the company because it would allow more flexibility as far as time is concerned.

“The FDA will classify the NDA resubmission as Class 1 or Class 2 upon acceptance of the resubmission,” stated a Business Wire publication.

TherapeuticsMD would thus be able to accelerate the timeline for the development which means it would get closer to launching the treatment in the market assuming it achieves desired results as well as regulatory approval. Every pharmaceutical company aims to get its developmental treatments in the market as fast as possible so that the years of research can finally start generating returns.

The company aims to use the TX-001HR developmental treatment to address mild-to-severe vasomotor symptoms as well as pains that occur during sexual intercourse for women during menopause. TherapeuticsMD also focuses on the manufacturing and distribution of generic as well as branded prenatal vitamin through the BocaGreenMD and vitaMedMD brands. The firm has focused heavily on the development of products that target the female demography. It is currently working on hormone therapy products that will facilitate the delivery of bio-identical hormones in various dosage forms.

TherapeuticsMD stock closed the latest trading session on Wednesday at $6.07 after rising by 0.83 percent from the previous close.


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