TherapeuticsMD Inc (NYSE:TXMD) has received a letter from the U.S. Food and Drug Administration (FDA) stating the position of the ongoing reviews of the company’s New Drug Application (NDA) for the TX-004HR.
The company expects that FDA will soon conclude their actions on the NDA for TX-004HR which is used to offer treatment in patients who experience moderate to severe dyspareunia (a vaginal pain occurrence during sexual intercourse) in women with post-menopausal conditions. The FDA had acknowledged some deficiencies in the new drug application that prevent further discussions on labeling and post-marketing activities by TherapeuticsMD.
The letter from FDA does not reveal the final decision on the ongoing investigations and the company is not yet aware of the nature of the deficiency underlined in the new drug application by the FDA. If the reviews are successfully approved by the FDA, the new applicator-free vaginal estradiol soft gel drug to relief pain in women who suffer from dyspareunia, an indication of vulvar and vaginal atrophy (VVA).
The company is continuously communicating with the FDA on the nature of the deficiencies in the NDA and is determined to get to the bottom of the matter immediately once they get the feedback. This is expected to be finalized on or before the previously scheduled Prescription Drug User Fee Act (PDUFA) action date, which is May 7, 2017.
The TherappeuticsMD is an innovative healthcare company that focuses on developing and distributing innovative products specifically meant to solve women problems throughout their life cycles. The company has for many years been involved in many advanced hormone therapies that help in delivering of bio-identical hormones in various dosage forms and administration paths.
The new drug application is one of the current late stage clinical products candidates that are in the final stages of implementation. Other products include the TX-001HR that will be used to treat moderate to severe vasomotor symptoms (VMS), conditions that come due to menopause in women. The feedback from FDA will determine whether the new drugs will be produced and distributed to the market or the company will have to undertake some changes before manufacturing the drugs.