The U.S. Food and Drug Administration (FDA) has approved elinzanetant for the reduction of menopause-related vasomotor symptoms known as hot flashes, according to a Bayer press release. This non-hormonal medication acts as a selective antagonist of neurokinin receptors types 1 and 3, inhibiting the action of substance P and neurokinin B. It is licensed for use in moderate to severe menopausal vasomotor symptoms.
The management's decision was based on the results of the multicenter, double-blind, randomized, placebo-controlled phase III trials OASIS 1, OASIS 2, and OASIS 3, which involved a total of 1,420 women. In these trials, elizanetant at a dose of 120 milligrams per day was significantly more effective than placebo (p < 0.001), reducing the frequency of hot flashes and the severity of symptoms with a satisfactory long-term safety profile.
