FDA approves New Drug Application for Duchesnay Inc. Osphena (aspemifene)

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of Osphena (aspemifene, opemifen) for the treatment of moderate to severe vaginal dryness, the(http://Prior to, Osphena had been approved for the treatment of moderate to severe sexual intercourse difficulties (sexual pain), a symptom of the menopausal VVAOsphenaOsphena is a tissue-selective estrogen agonist/antagonist that, by binding to estrogen receptors, leads to the activation of estrogen pathways (excitement) in certain tissues (excitable) and blocks other estrogen pathways (antagonists)Osphena is a non-hormonal drug that improves specific vaginal tissueby tissueby by increasing shallow cells, reducing the base cells and reducing vaginal acidityin many menopausal women, vaginal dryness is one of the two most annoying symptoms caused by VVAThe approval of Osphena's new indications, which will help more menopausal women, will provide an oral option for women who prefer non-hormonal treatment alternativesthis new indication approval is based on new efficacy and safety data from confirmed Phase III clinical studiesThe study, a randomized, double-blind, placebo-controlled, multicenter study, was conducted in patients with moderate to severe vaginal dryness and assessed the efficacy and safety of OsphenaBefore menopause, estrogen helps maintain the thickness, elasticity and lubrication of vaginal tissueHowever, as women age, estrogen levels decrease, leading to changes in these tissues, leading to dryness, itching, burning and pain in sexual intercourse