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Back To Vidyya FDA Approves Vaniqa For The Treatment Of Women With Unwanted Facial Hair

Can Women Really Say Good Bye To Unwanted Facial Hair?

Bristol-Myers Squibb Company and The Gillette Company have announced that the U.S. Food and Drug Administration (FDA) has approved 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, and was shown in controlled clinical trials to provide clinically meaningful and statistically significant improvement in the reduction of facial hair growth in women.

The FDA approval of Vaniqa may provide an important new option for the more than 41 million women in the United States with unwanted facial hair. Unwanted facial hair can affect women of all ages, races and ethnic backgrounds. The impact of this surprisingly common problem extends beyond the need for regular tweezing, waxing or depilatory application. Many women who have unwanted facial hair often report that the condition negatively impacts their lifestyle and makes them feel unfeminine and less confident.

"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., PhD, 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."

Vaniqa (eflornithine hydrochloride) Cream, 13.9% was developed through a unique partnership between The Gillette Company and Bristol-Myers Squibb. The companies formed the partnership in 1996 in order to complete development of the product. 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."

In most cases, unwanted facial hair is caused by hereditary factors. A small number of cases are caused by medical conditions such as androgen excess disorder or polycystic ovarian syndrome. Regardless of the cause, Vaniqa (eflornithine hydrochloride) 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. Vaniqa takes up to 2 months to work, and along with Vaniqa, women should continue to use their current method of hair removal.

Vaniqa has a unique mechanism of action and is believed to work by blocking an enzyme that is necessary for hair growth. In Phase III clinical trials, the primary study measure was a physician's global assessment of their patients' improvement at the end of 24 weeks. Results demonstrated clinically and statistically 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.

In clinical trials, when 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.

"Until now, no prescription creams have been available that help slow the rate of unwanted hair growth," said Mary Ann Pesce, vice president, New Products, The Gillette Company. "This unique partnership with Bristol-Myers Squibb reflects the ongoing commitment of The Gillette Company to develop products specifically designed to meet the grooming and beauty needs of women."

Women who are interested can learn more about Vaniqa by consulting with their physician or by calling 1-877-829-9715. Vaniqa will be available in pharmacies as early as September.

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Editor: Susan K. Boyer, RN
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