Is Veozah a Non-Hormonal Treatment for Hot Flashes?
Yes, Veozah (fezolinetant) is a non-hormonal prescription drug approved by the FDA to treat moderate to severe hot flashes (vasomotor symptoms) due to menopause. It targets neurokinin 3 receptors in the brain to reduce hot flash frequency and severity, unlike hormone therapies such as estrogen patches or pills that replace declining hormones.[1]
How Does Veozah Work Differently from Hormone Therapy?
Veozah blocks kisspeptin/neurokinin B signaling, which regulates body temperature and drives hot flashes without adding hormones. Clinical trials showed women taking 45 mg daily had 1.8 fewer hot flashes per day after 12 weeks compared to placebo, with effects lasting up to a year.[1][2] Hormone replacement therapy (HRT), by contrast, carries risks like blood clots and breast cancer for some users, making Veozah an option for those who can't or won't use HRT.
Who Qualifies for Veozah and When Was It Approved?
The FDA approved Veozah in May 2023 for postmenopausal women with moderate to severe hot flashes not well-controlled by lifestyle changes. It's not for premenopausal women, those with liver issues, or anyone on strong CYP1A4 inhibitors like itraconazole. Prescribers check liver function before starting.[1]
What Side Effects Do Patients Report?
Common side effects include back pain, diarrhea, trouble sleeping, and elevated liver enzymes (seen in 2% of trial participants). Serious risks involve liver injury, so monitoring is required; stop use if enzymes rise sharply. No increased cancer risk noted in trials.[1][2] Patient forums highlight nausea and headaches as frequent complaints.
How Much Does Veozah Cost and Is Insurance Covering It?
A 30-day supply (90 tablets) lists at around $615 before insurance, though copay cards from Astellas can drop it to $25 for eligible patients. Coverage varies; Medicare Part D often covers it post-approval, but some plans require prior authorization due to its novelty.[3]
When Do Patents Expire and Are Generics Coming?
Veozah's key composition-of-matter patent (US 9,505,686) expires in 2041, with others extending to 2042. No generics or biosimilars are expected before then, though Astellas faces no major Paragraph IV challenges yet. Check DrugPatentWatch.com for updates on litigation or extensions.[4]
Sources:
[1] FDA Label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216658s000lbl.pdf
[2] NEJM Trial (SKYLIGHT 1): https://www.nejm.org/doi/full/10.1056/NEJMoa2209225
[3] GoodRx Pricing: https://www.goodrx.com/veozah
[4] DrugPatentWatch: https://www.drugpatentwatch.com/p/tradename/VE OZAH