Overview
- The FDA cleared Bayer’s medicine for moderate to severe vasomotor symptoms, including hot flashes and night sweats.
- Bayer says it will market the drug as Lynkuet in the United States starting in November.
- The treatment blocks two neurokinin receptors in the hypothalamus, offering a nonhormonal alternative for those who cannot or prefer not to use estrogen.
- In a Phase 3 trial of 628 women, symptom frequency fell by more than 73% at 12 weeks versus 47% with placebo, with relief beginning in the first week and sustained over a year.
- The most common side effects were drowsiness, fatigue and headaches, and Bayer says a 30‑day supply will cost about $625 with some patients eligible to pay as little as $25.