CHMP Recommends Prasterone for VVA in Postmenopausal Women

Troy Brown, RN

November 10, 2017

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended marketing authorization for prasterone (Intarosa, Endoceutics Ltd) for the treatment of postmenopausal women with vulvar and vaginal atrophy and moderate to severe symptoms.

The US Food and Drug Administration approved prasterone for the relief of moderate to severe pain during sexual intercourse (dyspareunia) in postmenopausal women on November 17.

Prasterone is a naturally occurring steroid that acts through an estrogen-mediated mechanism to build up the number of superficial and intermediate cells in the vaginal mucosa and reduce the number of parabasal cells. It also facilitates the growth of normal bacterial flora by lowering the vaginal pH closer to the normal range.

The most frequently reported adverse effect of prasterone is vaginal discharge.

Prasterone, also known as dehydroepiandrosterone (DHEA), will be sold as a 6.5-mg pessary.

The summary of product characteristics will be published in the European public assessment report and will provide detailed recommendations for the use of prasterone. The recommendations will be available in all official European Union languages after the European Commission grants marketing authorization.

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