FDA approves Osphena (Shionogi) for Dyspareunia.
The FDA has approved Osphena (ospemifene), from Shionogi, for the treatment of moderate to severe Dyspareunia (painful intercourse), a symptom of Vulvar and Vaginal Atrophy (VVA), due to menopause. The efficacy and safety of Osphena was demonstrated in three clinical trials. Osphena demonstrated significant improvements in Dyspareunia as well as on the physical changes of the vagina associated with menopause.
These improvements include increased superficial cells and decreased parabasal cells and vaginal pH. As an oral medication taken once-daily, Osphena offers a convenient way for postmenopausal women to help treat dyspareunia.Shionogi expects to file an application for the medicine in Europe in March 2013.
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