Recently, Bayer (BAYRY. US) announced that its elinzanetant has been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK for the treatment of menopausal vasomotor symptoms (VMS, commonly known as hot flashes). Elinzanetant is the first non hormonal neurokinin-1.3 (NK-1,3) dual receptor antagonist, and this is the first time the product has been approved for use in hot flashes worldwide. This approval is based on the results of three Phase III clinical trials, OASIS -1, OASIS -2, and OASIS -3.
OASIS 1 and 2 are double-blind, randomized, placebo-controlled multicenter studies aimed at investigating the efficacy and safety of elinzanetant once daily oral therapy in women with moderate to severe VMS associated with menopause at 26 weeks. OASIS 1 and 2 randomly recruited 396 and 400 postmenopausal women aged 40-65 from 184 locations in 15 countries.
OASIS 3 is a double-blind, randomized, placebo-controlled multicenter study aimed at investigating the efficacy and safety of elinzanetant in treating vasomotor symptoms in postmenopausal women within 52 weeks. OASIS 3 randomly divided 628 postmenopausal women aged 40 to 65 from 83 centers in 9 countries.
The results showed that elinzanetant met all primary endpoints in these three studies and demonstrated good safety.
In OASIS 1 and OASIS 2 studies, compared to placebo, elinzanetant significantly reduced the frequency and severity of VMS. In addition, compared to placebo, elinzanetant achieved key secondary endpoints, showing a statistically significant decrease in VMS frequency from baseline to week 1, and improvement in sleep disorders and menopausal related quality of life.
In the OASIS -3 study, the frequency of VMS was statistically significantly reduced from baseline to week 12 compared to placebo. OASIS -3 further confirms the research results of OASIS -1 and OASIS -2, reporting sustained benefits and safety over a period of 52 weeks.