FDA Approves Novel Drug to Treat Moderate to Severe Menopause Hot Flashes

15 May 2023 • The U.S. Food and Drug Administration approved Veozah (fezolinetant), an oral medication for the treatment of moderate to severe hot flashes, caused by menopause. Veozah is the first neurokinin 3 (NK3) receptor antagonist approved by the FDA to treat moderate to severe hot flashes from menopause. It works by binding to and blocking the activities of the NK3 receptor, which plays a role in the brain’s regulation of body temperature.

Patients taking Veozah should take one 45 milligram pill orally, once a day, with or without food. The pill should be taken at the same time each day. The effectiveness of Veozah to treat moderate to severe hot flashes was demonstrated in each of the first 12-week, randomized, placebo-controlled, double-blind portions of two phase 3 clinical trials.

The prescribing information for Veozah includes a warning for elevated hepatic transaminase, or liver injury. Before using Veozah, patients should have blood work done to test for liver damage. While on Veozah, routine bloodwork should be performed every three months for the first nine months of using the medication.

Source: FDA | Read full story

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