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FDA Approves Low-Dose Local Oestrogen Therapy for the Treatment of Atrophic Vaginitis Due to Menopause PRINCETON, NJ -- December 2, 2009 -- The US Food and Drug Administration (FDA) has approved a 10-mcg dose formulation of Vagifem (oestradiol vaginal tablets) for the treatment of atrophic vaginitis due to menopause, a condition experienced by up to 75% of postmenopausal women. This approval makes Vagifem 10 mcg the lowest local oestrogen therapy (LET) dose available in the United States. Atrophic vaginitis is directly related to the loss of oestrogen associated with menopause. Caused by the resulting thinning and shrinking of vaginal tissues and the decreased lubrication of the vaginal walls, it can lead to vaginal dryness, soreness, vaginal and/or vulvar itching and irritation, painful sexual intercourse, and light bleeding after intercourse. The agent was first approved as a 25-mcg tablet in the United States in 1999 and in Europe in 1988. “This approval is good news for postmenopausal women who experience these symptoms. Now healthcare professionals can offer their patients a lower-dose treatment option that provides effective relief of their symptoms and improves their overall vaginal health,” said James A. Simon, MD, CCD, FACOG, George Washington University, Washington, DC. Dr. Simon was the lead physician on one of the Vagifem 10 mcg clinical trials submitted to the FDA. Unlike oral hormone therapy (HT), Vagifem 10 mcg delivers oestrogen directly to the vagina via a small tablet that is inserted using a ready-to-use applicator, with only minimal absorption throughout the body. The oestrogen in Vagifem 10 mcg, 17beta-estradiol, is chemically identical to oestrogen produced by a woman’s body before menopause. The approval of Vagifem 10 mcg is based on a randomised, placebo-controlled, 52-week multicentre trial, which found statistically significant improvement with Vagifem 10 mcg versus placebo after 12 weeks treatment in: · The relief of most bothersome symptoms of atrophic vaginitis as identified by patients, including vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, pain with urination, painful intercourse, and vaginal bleeding associated with intercourse. · The correction of important biologic markers, like vaginal pH and vaginal maturation index, to levels seen in non-menopausal women. One year of continuous treatment with Vagifem 10 mcg tablets was also safe and well-tolerated by patients. SOURCE: Novo Nordisk E-mail this page to a friend or colleague! To print, use this version