Moderate-to-severe vasomotor symptoms associated with menopause
Development and Regulatory status
Dec 17: TherapeuticsMD submitted the New Drug Application (NDA) for TX-001HR for treatment of moderate-to-severe vasomotor symptoms due to menopause, with the US FDA. The NDA submission is supported by the positive results of the PIII REPLENISH Trial.
Trial or other data
Apr 17: Additional safety and efficacy data from the PIII REPLENISH presented at the the 99th Annual Meeting of the Endocrine Society (ENDO-2017). The mean change in severity of hot flashes for all doses 1mg/100mg or 0.5mg/100mg of estradiol/progesterone was P< 0.05 and P< 0.001 from baseline for week 4 and week 12 respectively. For 0.5mg/50mg estradiol/progesterone vs placebo, hot flush frequency and severity significant imporved at week 12 from baseline (both, P< 0.05), while 0.25mg/50mg estradiol/progesterone vs placebo significantly improved only frequency at weeks 4 and 12 (both, P≤ 0.001). Co-primary efficacy endpoints and primary safety endpoint were met by both estradiol 1 mg/progesterone 100 mg and TX 001HR estradiol 0.5 mg/progesterone 100 mg doses. Mean change in frequency of hot flashes per week at week 4 was < 0.001 for estradiol 1 mg/ progesterone 100 mg and estradiol 0.25 mg/ progesterone 50 mg, respectively, while the mean change was 0.013 and 0.141 for estradiol 0.5 mg/ progesterone 100 mg and estradiol 0.5 mg/ progesterone 50 mg. Mean change in severity of hot flashes per week at week 4 ranged from 0.031 to 0.1. Secondary endpoint data also showed statistically significant improvement in both total and vasomotor menopause specific quality-of-life questionnaire (MENQOL) scores at week 12 and maintained through six and 12 months for these two doses of TX 001HR80. Treatment with four doses of estradiol/progesterone was generally safe and well tolerated. Headache, nasopharyngitis, breast tenderness, upper respiratory infection, nausea, back pain, and abdominal pain were the most common adverse events (> 5%). Somnolence with estradiol/ progesterone was reported in very low incidence. The incidence of consensus endometrial hyperplasia or malignancy was 0% across all four doses.[2,3]
Dec 16: Positive top-line data released from the REPLENISH trial.
Nov 16: TherapeuticsMD completed the double-blind PIII REPLENISH trial (NCT01942668; TXC12-05), which was initiated in 2013, in the US.