1. Health

FDA Approves Facial Hair Treatment


Updated April 04, 2010

The FDA has approved an important new treatment option for the more than 41 million women in the United States with unwanted facial hair. Unwanted facial hair affects women of all ages, races, and ethnic backgrounds.

The problem of unwanted facial hair extends beyond the normal need for tweezing, waxing, or depilatory application. Many women with excess facial hair suffer negative impact on their lifestyle that often makes them feel unfeminine and less confident.

The Bristol-Myers Squibb Company and The Gillette Company announced the FDA approval of Vaniqa (eflornithine hydrochloride) Cream, 13.9% as the first topical prescription treatment for women with unwanted facial hair. Vaniqa works by inhibiting the growth of facial hair. In controlled clinical trails, the drug was shown to clinically meaningful and statistically significant improvement in the reduction of facial hair growth in women.

"As a physician, I am excited about the potential for this new prescription cream to help women manage unwanted facial hair," said Marty E. Sawaya, M.D., Ph.D., adjunct professor, department of biochemistry and molecular biology, University of Miami, and a dermatologist and clinical research investigator at ARATEC Clinics in Ocala, Florida. "Importantly, Vaniqa will potentially help millions of women with this condition to feel less bothered by their facial hair and the amount of time they spend removing, treating, or concealing it."

A unique partnership, formed in 1996, between The Gillette Company and Bristol-Myers Squibb led to the development of Vaniqa Cream, 13.9%. Bristol-Myers Squibb is responsible for worldwide clinical development, regulatory submissions and, together with Gillette, is responsible for marketing this prescription product.

"Bristol-Myers Squibb is pleased that the FDA has approved Vaniqa as the first lifestyle prescription drug available to treat unwanted facial hair," said Richard J. Lane, president, Worldwide Medicines Group, Bristol-Myers Squibb. "As a result of our partnership with The Gillette Company, we can now provide physicians with an effective way to help their patients who are affected by this problem."

Hereditary factors are usually the cause of unwanted facial hair in women; however a small number of cases are caused by medical conditions such as androgen excess or polycystic ovary syndrome. Vaniqa Cream 13.9% demonstrated in clinical trials that it is effective in slowing the growth of unwanted facial hair in up to 60 percent of women without regard to cause.

Vaniqa can take up to 2 months to work, and women should continue to use their current hair removal method until the drug is working effectively. Vaniqa has a unique mechanism of action and is believed to work by blocking an enzyme that is necessary for hair growth.

After 24 weeks, patients in Phase III clinical trials, saw significant improvement in the reduction of facial hair growth in women treated with Vaniqa as compared to the group that was treated with vehicle (a placebo cream). Significant differences between Vaniqa and vehicle were seen as soon as eight weeks into treatment. The data from the Phase III clinical studies show that among those who completed 24 weeks of treatment, nearly 60 percent of patients on Vaniqa improved.

Side effects were mild and usually resolved without treatment. Minor skin irritations such as temporary redness, hair bumps, stinging, burning, tingling, acne, or rash were the most common side effects associated with Vaniqa.

Vaniqa is the first prescription cream available to help slow the rate of unwanted hair growth. Women can learn more about Vaniqa by consulting their physicians or by calling 1-877-829-9715. Vaniqa is expected to be available in pharmacies in September.

Full prescribing information for Vaniqa is available on the Bristol-Myers Squibb Company website.

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