TX-001HR

Unassigned

New Medicines

Moderate-to-severe vasomotor symptoms associated with menopause

Information

New molecular entity
TherapeuticsMD
TherapeuticsMD

Development and Regulatory status

None
None
Pre-registration (Filed)

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.[2]

Category

Bioidentical Hormone Replacement Therapy
Hot flushes and night sweats are experienced by around 80% of menopausal women; they are most common in the first year after menopause, but may persist for more than seven years in over half of women. Frequency and severity are highly variable but they can have a significant impact on quality of life causing sleep disturbance, loss of concentration, poor memory and features of depression [1].
Moderate-to-severe vasomotor symptoms associated with menopause
Oral

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.[3]


Nov 16: TherapeuticsMD completed the double-blind PIII REPLENISH trial (NCT01942668; TXC12-05), which was initiated in 2013, in the US.[3]