Estradiol + progesterone

Unassigned

New Medicines

Bijuve (UK), Bijuva (EU/US)Moderate to severe vasomotor symptoms associated with menopause

Information

Bijuve (UK), Bijuva (EU/US)
New formulation
Theramex
TherapeuticsMD

Development and Regulatory status

Approved (Licensed)
Approved (Licensed)
Launched
Apr 21Approved in UK and Belgium. Theramex expect approvals from other European countries to follow [7].
Oct 20Currently pre-registration in EU. Has been filed via the EU decentralised procedure [6].
Jun 19Theramex have acquired rights for commercialisation of estradiol and progesterone capsules (Bijuva) and estradiol vaginal inserts (Imvexxy) outside of the US, excluding Canada and Israel [5].
Apr 19Launched in the US [5].
Oct 18Approved in the US. Launch planned for Q2 2019 [4]
Dec 16TherapeuticsMD 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

Hormone Replacement Therapy - a bioidentical combination of 17β-estradiol and progesterone being developed as a soft-gel capsule, with the use of SYMBODA, a patented technology for solubilising bioidentical hormones [3]
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 17Additional 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 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 16Positive top-line data released from the REPLENISH trial.[3]
Nov 16TherapeuticsMD completed the double-blind PIII REPLENISH trial (NCT01942668; TXC12-05), which was initiated in 2013, in the US.[3]