Eflornithine chemical structure
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Vaniqa

Eflornithine (α-difluoromethylornithine or DFMO) is a drug manufactured by Sanofi-Aventis which has various uses. It was initially developed as a cancer medication; and while it has no significant effects on cancerous malignancies, it was found to be very effective in combatting African trypanosomiasis (sleeping sickness), in particular the West African form1 of the disease. It is hoped that eflornithine will replace the relatively toxic melarsoprol. Supplies of Eflornithine are limited as it is not very cost effective to manufacture. Aventis stopped making eflornithine in 1995 because of this very reason. more...

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The drug company gave the rights to manufacture the drug to the World Health Organization, who attempted to find a new supplier. Eflornithine is also an effective hair removal agent and is the active ingredient in Vaniqa brand hair removal cream.

Eflornithine appears to work by inhibiting ornithine decarboxylase (ODC), an enzyme that regulates cell division.

Sleeping Sickness Treatment

In 2001, Aventis made a 5-year agreement with the WHO to manufacture eflornithine, melarsoprol and pentamidine, in sufficient amounts to cover existing needs. The yearly value of the drugs donated by Aventis under this agreement is US$5 million. Medecins Sans Frontieres, or Doctors Without Borders, the non-profit international medical group, assisted in the creation of the new agreement. MSF will work to distribute the drugs. In addition, under the agreement, Bristol-Myers Squibb, the manufacturer of Vaniqua, will pay for part of the eflornithine. The 5-year agreement will expire in 2006. In 2004, Aventis merged with Sanofi-Sythélabo to form Sanofi-Aventis.

The trade name of eflornithine as manufactured for the treatment of sleeping sickness is Ornidyl®.

As of September 2005, the World Health Organization's eflornithine page is reporting that the India Institute of Chemical Technology in Hyderabad, India and ILEX Oncology in Texas, United States are both working on new ways of making eflornthine more cheaply. The WHO goes on to say that ILEX is experimenting with an oral formulation of the drug as a treatment for cancer and that trials of the new oral formulation for efficacy against sleeping sickness are underway.

Hair Removal Cream

As a topical application, the drug has been shown to be an effective hair growth retardant in some patients, and is sold under the brand name Vaniqa® (eflornithine hydrochloride 13.9%). Efficacy data submitted to FDA observed about 58% of women using it on facial hair had improvement2. This study suggested it may be particularly effective in postmenopausal women. One large published study on safety found the product rarely caused significant side effects such as acne, follicle irritation, itching or dryness3. This corroborates unpublished data submitted to FDA showing about 2% of subjects discontinued use due to adverse reactions.

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Vaniqa
From Family Pratice News, 9/15/00 by Elizabeth Mechcatie

(eflornithine cream, 13.9%, Bristol-Myers Squibb and Gillette) A topical prescription treatment for reducing unwanted facial hair in women.

* Dosage: A thin layer applied to affected areas twice a day at least 8 hours apart. Other hair removal techniques continue to be used as needed.

* Special Considerations: In trials, the most common side effects associated with eflornithine were minor skin irritations such as temporary redness, folliculitis, stinging, or rash, which were mild and "generally resolved without treatment, according to Bristol-Myers Squibb. Because there are no studies in pregnant women, the risk-benefit ratio of using Vaniqa during pregnancy "should be weighed carefully with serious consideration for either not implementing or discontinuing" the use of the product, the labeling says. Not known whether Vaniqa is passed to infants through breast milk.

* Comment: Vaniqa (pronounced VANN-i-ka) inhibits the activity of the enzyme or-nithine decarboxylase, which is found in hair follicles and is involved in hair growth. In two 24-week studies of 594 women, 32% of those treated with Vaniqa had at least "marked improvement" vs. 8% of those treated with a vehide cream. Those in the treatment group felt significantly less bothered about their facial hair and by the time they spent on removing, treating, or concealing facial hair. Vaniqa took up to 8 weeks to have an effect, and within 8 weeks of stopping treatment women returned to pretreatment levels of hair growth.

Dermatologist Elizabeth McBurney, who has not yet prescribed Vaniqa but is familiar with it, said that one of its advantages is that it works on hair of any color, while hair removal lasers work best on pigmented hair. Thus, Vaniqa should be helpful for women who have gray or white hair mixed in with darker hair, said Dr. McBurney, who plans to use it in conjunction with laser hair removal. "The disadvantages are that it has to be put on twice a day, it doesn't work overnight, and... you have to keep using it" to maintain the effect, added Dr. McBurney of Tulane University and Louisiana State University, New Orleans.

The cream has only been studied for reducing hair on the face and areas under the chin, but Dr. McBurney, who has no financial ties to the manufacturers, said that she would prescribe it for reducing hair growth on other parts of the body such as the axilla or legs. She also advised patients to test a small area of the skin first for an allergic reaction.

COPYRIGHT 2000 International Medical News Group
COPYRIGHT 2001 Gale Group

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