Bayer says FDA approves Lynkuet 60mg capsules for treatment of hot flashes

Bayer (BAYRY) announced today the U.S. Food and Drug Administration has approved Lynkuet 60mg capsules, the first and only dual neurokinin targeted therapy, neurokinin 1 and neurokinin 3 receptor antagonist, for the treatment of moderate to severe hot flashes due to menopause. Inhibition of Substance P and Neurokinin B through antagonism of NK1 and NK3 receptor signaling on kisspeptin/neurokinin B/dynorphin neurons can modulate neuronal activity in the thermoregulation associated with hot flashes. Lynkuet soft gel capsules are taken once daily at bedtime, with or without food. The FDA approval is supported by data from three Phase III clinical trials that evaluated the safety and efficacy of Lynkuet for the treatment of moderate to severe hot flashes due to menopause. “The FDA approval of Lynkuet is an important new option for women and providers who are treating moderate to severe hot flashes due to menopause,” said Yesmean Wahdan, M.D., Head of Medical Affairs USA & North America at Bayer. “As a global leader in women’s healthcare with more than 100 years of research and experience, we are proud to bring this new treatment option to market for women who are going through menopause and seeking hot flash relief.”