Wednesday, February 27, 2013

SHIONOGI RECEIVES FD A APPROVAL FOR OSPHENA TM (OSPEMIFENE) FOR THE TREATMENT OF DYSPAREUNIA , A SYMPTOM OF VULVAR AND VAGINAL ATROPHY (VVA) , DUE TO MENOPAUSE

 Shionogi Inc., has receivedthe U.S. Food and Drug Administration (FDA) approval for OsphenaTM (ospemifene) tablets for the treatment of moderate to severe dyspareunia (painfulintercourse), a  symptom of vulvar and vaginal atrophy (VVA), due to menopause. Osphena is an estrogen agonist / antagonist with tissue selective effects. It is the first and only oral treatment alternative to vaginal or oral steroidal estrogens for women with dyspareunia due to menopause. Its biological actions are mediated through binding to estrogen receptors, which results inactivation of estrogenic pathways in some tissues and blockage of estrogenic pathways in others. The efficacy and safety has been validated in three clinical trials. Osphena TM demonstrated significant improvement s in dyspareunia (painful intercourse)
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





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