FDA Approves Facial Hair Removal Cream

Company Says 41 Million Women Will Benefit

PRINCETON, N.J., Updated 12:39 p.m. EDT August 7, 2000 -- The Food and Drug Administration has approved the first topical prescription treatment for women with unwanted facial hair.

Bristol-Myers Squibb Co. and The Gillette Co. announced last Tuesday that the FDA has given them the green light to distribute a cream called VANIQA.

Bristol-Myers Squibb officials said that VANIQA is the first topical prescription treatment for women with unwanted facial hair.

VANIQA works by inhibiting the growth of facial hair, and was shown in clinical trials to provide clinically meaningful and statistically significant improvement in the reduction of facial hair growth in women, company officials said.

According to the company's Web site, more than 41 million women in the U.S. have unwanted facial hair, a condition that can affect women of all ages, races and ethnic backgrounds. In most cases, unwanted facial hair is caused by hereditary factors.

In clinical trials, among those who completed 24 weeks of treatment, nearly 60 percent of patients using VANIQA improved. Significant differences using VANIQA were seen as soon as eight weeks into treatment, company officials said.

In clinical trials, if side effects occurred, they were mild and generally resolved without treatment. The most common side effects associated with VANIQA were minor skin irritations such as temporary redness, hair bumps, stinging, burning, tingling, acne or rash.

Along with VANIQA, women should continue to use their current method of hair removal.

VANIQA will be available by prescription and should be in pharmacies in early September.

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