The US Food and Drug Administration has approved Noven Pharmaceuticals’ Brisdelle, the first non-hormonal therapy to get the green light for hot flushes associated with menopause.
Brisdelle contains low-dose paroxetine, (unlike the higher-dose paroxetine antidepressants Paxil/Seroxat from GlaxoSmithKline and Noven’s own Pexeva). There are a variety of FDA-approved treatments for hot flushes, but all contain either oestrogen alone or oestrogen plus a progestin.
Hylton Joffe, director of the division of bone, reproductive and urologic products in the FDA’s Center for Drug Evaluation and Research, noted that “there are a significant number of women who suffer from hot flushes associated with menopause and who cannot or do not want to use hormonal treatments”. They occur in up to 75% of women and can persist for up to five years.
The safety and effectiveness of Brisdelle were established in two studies involving 1,175 postmenopausal women where treatment reduced hot flushes compared to placebo. The mechanism by which this happens is unknown.
The most common side effects in patients treated with Brisdelle were headache, fatigue, and nausea/vomiting. The label covers the same advice as antidepressant-use paroxetine, notably a boxed warning about suicidality.
Joel Lippman, chief medical officer at Noven, which is owned by Japan’s Hisamitsu Pharmaceutical Co, said the approval “meaningfully expands the therapeutic options for the 24 million women in the USA affected…two-thirds of whom are not currently treating these often debilitating symptoms”. Brisdelle will be available in pharmacies in November.
