(dailyRx)

The FDA has approved a 10 mcg dose formulation of Vagifem (estradiol vaginal tablets) to treat atrophic vaginitis due to menopause, a condition experienced by up to 75 percent of postmenopausal women.
This approval makes Vagifem 10 mcg the lowest local estrogen therapy (LET) dose commercially available in the U.S. It will be available in the first quarter of 2010.

Atrophic vaginitis, commonly referred to as vaginal atrophy, is directly related to the loss of estrogen associated with menopause. It is caused by the resulting thinning and shrinking of vaginal tissues and the decreased lubrication of the vaginal walls, which can lead to vaginal dryness, soreness, vaginal and or vulvar itching and irritation, painful sexual intercourse and light bleeding after intercourse.

Vagifem was first approved as a 25 mcg tablet in the U.S. in 1999.

"This approval is good news for postmenopausal women who experience these symptoms. Now health care 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, M.D., C.C.D., F.A.C.O.G., clinical professor of obstetrics and gynecology at George Washington University and the lead physician on one of the Vagifem 10 mcg clinical trials submitted to the FDA.

Unlike oral hormone therapy, Vagifem 10 mcg delivers estrogen directly to the vagina via a small tablet, with only minimal absorption throughout the body. The estrogen in Vagifem, 17beta-estradiol, is chemically identical to estrogen produced by a woman's body before menopause.

The approval of Vagifem 10 mcg is based on a randomized, placebo-controlled, 52-week, multicenter trial that found statistically significant improvement with Vagifem 10 mcg versus placebo after 12 weeks of treatment in the following areas:

  • Relief of most bothersome symptoms of atrophic vaginitis as identified by patients, including vaginal dryness, vaginal or vulvar irritation or itching, vaginal soreness, pain with urination, painful intercourse and vaginal bleeding associated with intercourse
  • Correction of important biologic markers, such as vaginal pH and vaginal maturation index, to levels seen in nonmenopausal women

One year of continuous treatment with Vagifem 10 mcg tablets was also safe and well-tolerated by patients.

Contact:
Ambre Morley
609-987-5898