Neurokinin Receptor Antagonist, Fezolinetant, for Treatment of Menopausal Vasomotor Symptoms

Pinkerton, JoAnn V.; Redick, Dana L.; Homewood, Laura N.; Kaunitz, Andrew M.

doi:10.1210/clinem/dgad209

Cited by 4 publications

(2 citation statements)

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“…22 A single-mechanism NK-3 receptor antagonist fezolinetant has recently received FDA approval and CHMP positive opinion for specifically treating VMS, with phase 3 trials showing efficacy and mild liver function abnormalities that were mild and resolved [33][34][35] ; therefore, the FDA has recommended liver function testing during the first 9 months. 36 Of note, no clinically significant liver enzyme elevations were considered related to treatment with elinzanetant in phase 2 trials and no other safety concerns were observed in phase 1 and 2 trials that prevented moving to phase 3. 14,15,37,38 However, close attention will be paid to participants who experience elevations in liver enzymes in the OASIS trials as a precautionary measure to address concerns regarding liver toxicity in single-mechanism NK-3 receptor antagonists, which have a substantially different molecular structure compared with elinzanetant, a selective NK-1,3 receptor antagonist.…”

Section: Discussionmentioning

confidence: 99%

“…A single-mechanism NK-3 receptor antagonist fezolinetant has recently received FDA approval and CHMP positive opinion for specifically treating VMS, with phase 3 trials showing efficacy and mild liver function abnormalities that were mild and resolved 33–35 ; therefore, the FDA has recommended liver function testing during the first 9 months 36 …”

Section: Discussionmentioning

confidence: 99%

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Design of OASIS 1 and 2: phase 3 clinical trials assessing the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause

Pinkerton,

Simon,

Panay

et al. 2024

Menopause

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Objective Elinzanetant is a selective neurokinin-1,3 receptor antagonist in development for the treatment of vasomotor symptoms (VMS) associated with menopause. The pivotal, double-blind, randomized, placebo-controlled phase 3 studies Overall Assessment of efficacy and Safety of elinzanetant In patients with vasomotor Symptoms (OASIS) 1 and 2 will assess the efficacy and safety of elinzanetant in women with VMS. Methods The OASIS 1 and 2 pivotal studies are designed in accordance with regulatory guidance. Postmenopausal women with moderate/severe VMS are randomized to receive 120 mg elinzanetant or placebo once daily for 12 weeks, followed by a 14-week active treatment extension. Primary endpoints are the mean change in frequency and severity of moderate/severe VMS from baseline to weeks 4 and 12. Key secondary endpoints will assess the onset of action and effects on sleep disturbance and menopause-related quality of life. Primary and key secondary endpoints will be analyzed using a mixed model with repeated measures. Feedback from postmenopausal women with VMS was used during protocol development. Results Women confirmed the relevance of endpoints that assess the impact of VMS, sleep disturbance, and mood changes, and the need for new nonhormone treatments. Educational materials around study design, conduct and expected assessments and procedures were developed based on questions and concerns raised by women. Conclusions The OASIS 1 and 2 pivotal phase 3 studies will enable assessment of the efficacy and safety of elinzanetant as a treatment for VMS, together with its effect on sleep disturbances, depressive symptoms, and menopause-related quality of life. Feedback from postmenopausal women with VMS was used to maximize patient centricity in the trials.

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