Vaniqa medical data

Some recent data on Vaniqa and its active ingredient:

Shapiro (2001): Vaniqa overview

A general overview.

Malhotra (2001): Vaniqa absorption data

Ten women underwent tests to measure the amount of eflornithine HCl absorbed through the skin by the body. Results showed minimal absorption and a safe clinical profile.

Balfour (2001): Vaniqa overview

Published version of the study submitted to FDA showing 58% of women had improvement.

For more information on this interesting drug, please see:
Hairfacts: Vaniqa

[ May 09, 2002, 10:08 AM: Message edited by: Andrea ]

Medline Plus has a reliable overview, too:

Medline Plus Vaniqa overview

Here’s a copy of a press release from 2000, when Vaniqa was released:

Eflornithine Cream Approved by FDA as Treatment for
Unwanted Facial Hair
August 3, 2000
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.

Below is a pre-approval report on Dr. Sawaya’s work with Vaniqa under clinical conditions.

AAD: Eflornithine Hcl 15% Cream Slows Excessive Growth Of Facial Hair

SAN FRANCISCO, CA – March 10, 2000 – The results of Phase III studies involving Eflornithine HCl 15%, a topical facial cream, demonstrate significant inhibition in the rate of facial hair growth in women. The results of the Phase III trials, involving 596 women, were presented today during the 58th Annual Meeting of the American Academy of Dermatology in San Francisco, California.

It is estimated that more than 20 million American women in the United States have excessive facial hair. Excessive facial hair may be caused by hereditary factors, part of the normal aging process, or by medical conditions such as androgen excess disorder or polycystic ovarian syndrome. Women with excessive facial hair often experience psychological factors such as low self-esteem and embarrassment.

“Until now there have been no topical creams which help slow the rate of excessive hair growth,” said Marty Sawaya, M.D., Ph.D., principal investigator in the studies, adjunct professor, department of biochemistry and molecular biology at the University of Miami, and dermatologist at ARATEC Clinics in Ocala, Florida. “Women have been able to temporarily control this condition by shaving, tweezing or waxing. Based on the results of these studies, Eflornithine HCl 15% is the first topical cream that inhibits the growth rate of facial hair, thereby reducing the amount of time women have to spend managing it.”

Eflornithine HCl cream 15% has a unique mechanism of action and works by blocking an enzyme that stimulates hair growth. The Eflornithine HCl cream 15% Phase III studies were conducted to evaluate the safety and efficacy of the topical cream in the treatment of women with excessive facial hair. Approximately 596 women with excessive facial hair were randomized to Eflornithine HCl cream 15% or vehicle. The adult women who participated in the study represented a variety of ethnic groups, including Caucasians, Hispanics and African-Americans. Study treatments were applied twice daily for 24 weeks followed by an eight-week period of no treatment. Evaluations were made 48 hours after women removed facial hair.

In the Phase III studies, the primary measure of efficacy was a physician’s global assessment of improvement. The results of the physician’s global assessment at the end of the 24-week studies demonstrate significant improvement in the reduction of facial hair growth in women treated with the Eflornithine HCl cream 15% as compared to the group that was treated with vehicle (P is less than or equal to 0.001). The data from the two studies show that overall 70 percent of patients improve, and 35 percent of participants in the Eflornithine HCl group are rated as clinical successes (marked improvement or clear/almost clear) compared to nine percent in the vehicle group. The significant difference between participants on Eflornithine HCl cream 15% and those on vehicle was seen as early as after four weeks of treatment (P=0.017) in one study and after eight weeks of treatment (P is less than or equal to 0.001) in the second study. In addition, another 35 percent of participants treated with Eflornithine HCl cream 15% showed some improvement.

The reports of treatment-related adverse events with Eflornithine HCl 15% were generally comparable to vehicle. Most adverse events were mild and included stinging, burning, tingling, pseudofolliculitis barbae (PFB) and acne.

“Excessive facial hair is not only embarrassing for women – it is also time consuming to manage and can impact upon patients’ self-esteem,” said Dr. Sawaya. “As a practicing physician, I am excited about the results of the Phase III Eflornithine HCl 15% studies and the potential for a new option to help patients manage this condition.”

ARATEC Clinics conduct clinical trials in dermatology in conjunction with the University of Miami. ARATEC Clinics are based in Ocala, Florida.