TherapeuticsMD, Inc. (NASDAQ:TXMD), an innovative women’s healthcare company, today announced the acceptance of the New Drug Application (NDA) resubmission for TX-004HR, the company’s investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause, by the U.S. Food and Drug Administration (FDA).
The FDA has acknowledged that the resubmission is a complete, class 2 response to the Complete Response Letter (CRL) received on May 5, 2017 for TX-004HR. The PDUFA target action date for the completion of the FDA’s review is May 29, 2018.
The FDA has informed the Company that the additional endometrial safety information submitted to the NDA for TX-004HR on September 14, 2017 was outside of an official review cycle, thus procedurally designating a class 2 response. The Company currently plans to launch TX-004HR in the third quarter of 2018 if approval occurs on or before the PDUFA target action date.
“The acceptance of the NDA resubmission for TX-004HR is an important milestone for TherapeuticsMD and this PDUFA target action date will allow us to maintain our timelines for launch as early as July 2018,” said TherapeuticsMD CEO Robert G. Finizio. “If approved, TX-004HR has the potential to be a highly differentiated treatment option for the 32 million postmenopausal women in the United States who suffer from symptoms of VVA.”
The 505(b)(2) NDA resubmission for TX-004HR is supported by the complete TX-004HR clinical program, including positive results of the phase 3 Rejoice Trial, which evaluated the effect of three doses of TX-004HR (4 mcg, 10 mcg and 25 mcg) compared to placebo from baseline to week 12. The results demonstrated statistically significant and clinically meaningful improvements in dyspareunia, a co-primary endpoint, and vaginal dryness, a prespecified secondary endpoint. Statistically significant results were seen as early as two weeks of treatment. The NDA resubmission includes the 4 mcg and 10 mcg doses of TX-004HR.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an innovative healthcare company focused on developing and commercializing products exclusively for women. With its SYMBODA™ technology, TherapeuticsMD is developing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. The company’s late stage clinical pipeline includes two phase 3 product candidates: TX-001HR for treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause and TX-004HR for treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. The company also manufactures and distributes branded and generic prescription prenatal vitamins under the vitaMedMD® and BocaGreenMD® brands.