FDA Approves Novel Hot Flash Therapy Lynkuet
The Food and Drug Administration (FDA) has approved Lynkuet® (elinzanetant) for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause.
Lynkuet is a dual neurokinin-1,3 (NK-1,3) receptor antagonist that reduces the frequency and severity of VMS by modulating the KNDy (kisspeptin, neurokinin B, and dynorphin) neurons, a group of estrogen sensitive neurons in the hypothalamus region of the brain.
The approval was based on data from the OASIS 1 (ClinicalTrials.gov Identifier: NCT05042362) and OASIS 2 (ClinicalTrials.gov Identifier: NCT05099159) clinical trials, which included 796 menopausal women who had at least 50 moderate to severe hot flashes, including nighttime hot flashes, per week. Study participants (mean age, 54.5 years) were randomly assigned to receive elinzanetant 120mg or placebo, once daily at bedtime for 12 weeks.
The primary endpoint was the mean change in frequency and severity of moderate to severe VMS from baseline to weeks 4 and 12, including day and night hot flashes measured using the Hot Flash Daily Diary (HFDD).