TherapeuticsMD Announces FDA Acceptance of New Drug Application (NDA) and Prescription Drug User Fee Act (PDUFA) Date for TX-001HR
The FDA in its 74-day letter stated that the application is sufficiently complete to permit a substantive review and that, at this time, the FDA has not identified any potential review issues. The FDA noted that the filing review is only a preliminary evaluation of the application and is not indicative of deficiencies that may be identified during the FDA’s review. The PDUFA target action date for the completion of the FDA's review is October 28, 2018.
“The acceptance of the NDA for TX-001HR is another important milestone for TherapeuticsMD and reaffirms the strength and commitment of our organization,” said TherapeuticsMD CEO Robert G. Finizio. “If approved, TX-001HR has the potential to be the first and only combination of bio-identical estradiol and bio-identical progesterone in a single, oral softgel to meet the needs of patients, physicians, and pharmacies as an FDA-approved, third-party reimbursed treatment option for women suffering from moderate-to-severe vasomotor symptoms due to menopause.”
The 505(b)(2) NDA submission for TX-001HR is supported by the complete TX-001HR clinical program, including positive results of the phase 3 Replenish Trial, which evaluated the safety and efficacy of four doses of TX-001HR (1 mg estradiol/100 mg progesterone, 0.5 mg estradiol/100 mg progesterone, 0.5 mg estradiol/50 mg progesterone, 0.25 mg estradiol/50 mg progesterone) compared to placebo. The co-primary efficacy endpoints in the Replenish Trial were the change from baseline in the number and severity of hot flashes at weeks 4 and 12 as compared to placebo. The primary safety endpoint was the incidence of endometrial hyperplasia with up to 12 months of treatment. General safety was also evaluated. Both the 1 mg estradiol/100 mg progesterone and the 0.5 mg estradiol/100 mg progesterone doses achieved statistically significant and clinically meaningful results across the four co-primary efficacy endpoints. In addition, the incidence rate of endometrial hyperplasia was 0% across all doses with up to 12 months of treatment, meeting the primary safety endpoint of less than 1% incidence of endometrial hyperplasia.
TX-001HR is the company’s investigational bio-identical hormone therapy combination of estradiol and progesterone in a single, oral softgel for the treatment of moderate-to-severe vasomotor symptoms due to menopause.
About Menopause and Vasomotor Symptoms (VMS)
Menopause is a natural life-stage transition for women with an average onset of 51 years. According to the United States Census Bureau, approximately 43 million women in the U.S. are of menopausal age (45-64 years).
As the ovaries stop producing hormones, levels of circulating estrogen decrease, often causing vasomotor symptoms (VMS) such as night sweats, hot flashes, and sleep disturbances. VMS affect as many as 60-80 percent of all menopausal women.
Menopausal women can benefit from hormone therapy (HT), also known as hormone replacement therapy (HRT), which is recognized by key medical societies as the most effective treatment for relief of symptoms related to menopause.