FDA Accepts NDA for Bio-Identical Combination Hormone Therapy

TherapeuticsMD announced that the Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for TX-001HR, an oral hormone combination therapy, for the treatment of moderate-to-severe vasomotor symptoms due to menopause.

TX-001HR is an investigational bio-identical hormone therapy combining estradiol and progesterone in an oral softgel. The NDA submission was  supported by data from the TX-001HR clinical program, including the Phase 3 Replenish Trial which compared 4 doses of TX-001HR (1mg estradiol/100mg progesterone, 0.5mg/100mg, 0.5mg/50mg, 0.25mg/50mg) vs placebo. The co-primary endpoints were the change from baseline in the number and severity of hot flashes at Weeks 4 and 12 vs placebo; the primary safety endpoint was the incidence of endometrial hyperplasia with up to 12 months of therapy.

The data showed that the 1mg/100mg and 0.5mg/100mg doses achieved statistically significant and clinically meaningful results across the co-primary efficacy endpoints. Moreover, there was 0% incidence of endometrial hyperplasia for all doses with up to 12 months of treatment, achieving the primary safety endpoint of <1% incidence rate. 

“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,” said Robert G. Finizio, CEO of TherapeuticsMD.

The FDA has set a target Prescription Drug User Fee Act (PDUFA) date of October 28, 2018.

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