Eflornithine Cream Approved by FDA as Treatment for Unwanted Facial Hair

August 03, 2000

New York (MedscapeWire) Aug 3 - Bristol-Myers Squibb Company and The Gillette Company have announced that the US Food and Drug Administration (FDA) has approved eflornithine hydrochloride cream, 13.9% ( Vaniqa), as the first topical prescription treatment for women with unwanted facial hair. Eflornithine 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 eflornithine 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, MD, 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, [eflornithine] 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."

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 ovary syndrome. Regardless of the cause, eflornithine cream demonstrated in clinical trials that it is effective in slowing the growth of unwanted facial hair in up to 60% of women. Eflornithine takes up to 2 months to work, and along with eflornithine, women should continue to use their current method of hair removal.

Eflornithine 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 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 eflornithine compared with the group that was treated with a placebo cream. Significant differences between eflornithine and placebo were seen as soon as 8 weeks into treatment. The data from the phase III clinical studies show that among those who completed 24 weeks of treatment, nearly 60% of patients receiving eflornithine improved.

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

Eflornithine cream is expected to be available in pharmacies as early as September.


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