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
"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
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
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.