Ospemifene (Senshio, Shionogi Limited) was recommended by a European Medicines Agency (EMA) panel for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy in postmenopausal women who are unable to use local vaginal estrogen therapy, according to an agency news release.
The EMA's Committee for Medicinal Products for Human Use recommended marketing authorization for ospemifene after reviewing quality, safety, and efficacy data.
Ospemifene is a selective estrogen receptor modulator (ATC code G03XC05) that, along with its primary metabolite, binds to estrogen receptors to activate estrogenic pathways in some tissues (agonism) and block estrogenic pathways in other tissues (antagonism). It is available in 60-mg tablets.
Ospemifene improves vaginal pH levels, matures the vaginal epithelium, and relieves troublesome symptoms, including vaginal dryness and dyspareunia (painful intercourse). The most frequently reported adverse effect was hot flushes.
The US Food and Drug Administration approved ospemifene for the treatment of dyspareunia in February 2013 after reviewing data from three clinical trials of 1889 postmenopausal women suffering from vulvar and vaginal atrophy. In those studies, women were randomly assigned to receive either ospemifene or a placebo. After 12 weeks of treatment, women in the first two studies who received ospemifene experienced significantly improved dyspareunia compared with women who received placebo. The third study demonstrated ospemifene's long-term safety in women with dyspareunia.
The marketing authorization includes implementation of a pharmacovigilance plan.
The European public assessment report will include detailed recommendations for ospemifene's use in the summary of product characteristics, which will be available in all official European Union languages after the European Commission grants marketing authorization.
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Cite this: EMA Backs Ospemifene (Senshio) for Vulvar and Vaginal Atrophy - Medscape - Nov 21, 2014.
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