FDA Approves 10 Mcg Dose Of Vagifem® For The Treatment Of Atrophic Vaginitis Due To Menopause

Main Category: Women's Health / Gynecology
Also Included In: Endocrinology;  Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 03 Dec 2009 - 2:00 PST

email to a friend   printer friendly   opinions  

Nordisk said that the U.S. Food and Drug Administration (FDA) has approved a 10 mcg dose formulation of Vagifem® (estradiol vaginal tablets) for the treatment of 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 pharmacies 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® is the only prescription vaginal tablet in a ready-to-use applicator designed to relieve the symptoms and discomfort associated with atrophic vaginitis.

Vagifem® was first approved as a 25 mcg tablet in the U.S. in 1999 and in 1988 in Europe.

"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, Clinical Professor of Obstetrics and Gynecology, George Washington University, Washington, D.C. 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 estrogen directly to the vagina via a small tablet that is easy to insert by a ready-to-use applicator, with only minimal absorption throughout the body. The estrogen in Vagifem® 10 mcg, 17beta-estradiol, is chemically identical to estrogen produced by a woman's body before menopause.

"We are very pleased to offer the millions of postmenopausal women who experience symptoms associated with vaginal atrophy a lower dose treatment option that works at the location of their discomfort," said Eddie Williams, Vice President of Biopharmaceuticals at Novo Nordisk. "Vagifem® 10 mcg effectively addresses a spectrum of symptoms, such as vaginal dryness, itching, and painful intercourse, that can disrupt their day-to-day lives."

The approval of Vagifem® 10 mcg is based on a randomized, placebo-controlled 52-week multicenter 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.

Important Safety Information

What is the most important information you should know about Vagifem® (an estrogen hormone)?

Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using Vagifem®. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find the cause.

Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia (decline of brain function).

Using estrogen-alone may increase your chances of getting strokes or blood clots.

Using estrogen-alone may increase your chance of getting dementia, based on a study of women age 65 years or older.

Do not use estrogens with progestins to prevent heart disease, heart attack, or dementia.

Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.

Using estrogens with progestin may increase your chance of getting dementia, based on a study of women 65 years and older.

You and your healthcare provider should talk regularly about whether you still need treatment with Vagifem®.

Vagifem® is used after menopause to treat menopausal changes in and around the vagina.

Do not start using Vagifem® if you: have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack, currently have or have had blood clots, currently have or have had liver problems, are allergic to Vagifem® or any of its ingredients or think you may be pregnant.

The most commonly reported side effects of Vagifem® included: headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea and vomiting, hair loss, fluid retention and vaginal yeast infection.

Vagifem® is a registered trademark of Novo Nordisk FemCare AG.

Novo Nordisk is a healthcare company with an 86-year history of innovation and achievement in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition to diabetes care, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy, and hormone therapy for women. Novo Nordisk's business is driven by the Triple Bottom Line: a commitment to economic success, environmental soundness, and social responsibility to employees and customers. With headquarters in Denmark, Novo Nordisk employs more than 26,000 employees in 80 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'.

Source: Novo Nordisk

• Additional
• References
• Citations