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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Barrier Therapeutics Announces the Launch of VANIQA(R) in Canada
From Market Wire, 11/3/05

Barrier Therapeutics, Inc. (NASDAQ: BTRX), a pharmaceutical company developing and commercializing products in the field of dermatology, today announced the commercial launch of VANIQA® (eflornithine hydrochloride) Cream, 13.9% in Canada. Barrier Therapeutics acquired the exclusive right to distribute VANIQA® in Canada from Shire Pharmaceutical Contracts Limited in June 2005. VANIQA® is the only topical prescription product approved by Health Canada for slowing the growth of unwanted facial hair in women.

"We are very excited about the launch of VANIQA® in Canada," said Joan Chypyha, General Manager of Barrier Therapeutics in Canada. "Now, physicians in Canada have available a unique treatment option for female patients that suffer from excessive facial hair. Currently, this is the only topical prescription product available in Canada for treating this condition."

Excessive facial hair can be very distressing for women and can be associated with social and psychological difficulties including anxiety and social avoidance. VANIQA®, when used together with traditional hair removal methods, reduces the growth rate of facial hair in women by blocking an enzyme that is necessary for hair growth. VANIQA® has been studied in over 1,800 women in clinical trials in which subjects were treated twice daily for 24 weeks. Statistically significant improvements were noted in as few as 4 weeks of treatment and at 24 weeks of treatment VANIQA® was statistically and clinically superior to vehicle (p=0.001). With its unique non-hormonal mode of action, it is effective on all hair types and may offer both functional and emotional benefits to patients.

"The launch of VANIQA® in Canada represents a significant milestone for Barrier Therapeutics as we continue to build upon our global commercialization plans," said Al Altomari, Chief Commercial Officer. "With an experienced sales and marketing team in place, we believe we are well positioned to successfully market this product."

VANIQA® is now the second product marketed and sold in Canada by Barrier Therapeutics. Solagé®(mequinol 2%, tretinoin 0.01%) Topical Solution, for the treatment for age spots, is currently marketed and sold by Barrier in both the United States and Canada.

To obtain more information about VANIQA®, call 1-866-440-5507.

About Barrier Therapeutics, Inc.

Barrier Therapeutics, Inc. is a pharmaceutical company focused on the discovery, development and commercialization of pharmaceutical products in the field of dermatology. The Company currently markets Solagé® (mequinol 2%, tretinoin 0.01%) Topical Solution in the U.S. and Canada for the treatment of solar lentigines, a common condition also known as "age spots," and markets VANIQA® (eflornithine hydrochloride) Cream 13.9% for slowing the growth of unwanted facial hair in women in Canada. Barrier has eight product candidates in various stages of clinical development. The four most advanced product candidates include Vusion(TM) (formerly known as Zimycan(TM)) for the treatment of diaper dermatitis complicated by candidiasis, which is under FDA review, and three products, which are in or entering Phase 3 clinical trials for the treatment of seborrheic dermatitis, onychomycosis, and congenital ichthyosis. Barrier has product candidates in earlier stages of clinical development for the treatment of acne, psoriasis and fungal infections. The Company is headquartered in Princeton, New Jersey and has wholly owned subsidiaries in Geel, Belgium and Ontario, Canada. Web site: http://www.barriertherapeutics.com.

Safe Harbor Statement

In addition to historical facts or statements of current condition, this press release contains forward-looking statements within the meaning of the "Safe Harbor" provisions of The Private Securities Litigation Reform Act of 1995, including statements regarding Barrier's plans for commencing commercialization of VANIQA®. Forward-looking statements provide Barrier's current expectations or forecasts of future events. Barrier's performance and financial results could differ materially from those reflected in these forward-looking statements due to the decisions of regulatory authorities, Barrier's ability to implement its commercial plans, the market acceptance of VANIQA®, general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries generally. For a discussion of these and other risks and uncertainties that may effect the forward-looking statements please see the risk factors in our Annual Report on Form 10K, which is on file with the Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Barrier undertakes no obligation to update publicly any forward-looking statement.

Contact: Barrier Therapeutics, Inc. Anne M. VanLent 609-945-1202 Barrier Therapeutics Canada Joan Chypyha 905-773-0066 Noonan Russo Jane Petrino 212-845-4274

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