Eflornithine

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Eflornithine

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 its West African form (Trypanosoma brucei gambiense)Pepin J, Milord F, Guern C, Schechter PJ. Difluoromethylornithine for arseno-resistant Trypanosoma brucei gambiense sleeping sickness. Lancet 1987;2(8573):1431-3. PMID 2891995.

Sleeping sickness treatment

Function

Eflornithine appears to kill trypanosomes by acting as a suicide inhibitor of the enzyme ornithine decarboxylase (), this enzyme regulates cell division by catalysing the first step in polyamine biosynthesis.

Eflornithine's effects against Trypanosoma brucei gambiense were discovered by chance and because its ability to bring patients back from coma, it became known as "Resurrection Drug".

It is hoped that eflornithine will replace the relatively toxic melarsoprol.

Production

Supplies of Eflornithine are limited as its manufacturer does not consider it cost effective.

Its production was halted by its manufacturer, Aventis, in 1995 because the company did not consider it a profitable drug. The disease mainly affects poor people unable to pay for any sort of treatment.

In 2001, after heavy lobbying by Medecins Sans Frontieres ("Doctors Without Borders"), the international medical NGO, and the World Health Organization, the manufacturer agreed to resume production of Eflornithine, Melarsoprol and Pentamidine, in sufficient amounts to cover existing needs. This 5-year agreement with the WHO also envisaged MSF working on the distribution of the drugs. The yearly value of the drugs donated by Aventis under this agreement is US$5 million. 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 2006http://www.ifpma.org/Health/other_infect/health_sleep.aspx. The trade name of eflornithine as manufactured for the treatment of sleeping sickness is Ornidyl®.

Once the five years period is over, Sanofi-Aventis (its new name after merging with another drugs company, Sanofi-Sythélabo) would start transferring technology and giving tecnical assistance to any possible manufacturer willing to continue production on their own.http://www.dndi.org.br/Espanhol/doenca_sono.aspx

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

Eflornithine is also an effective hair removal agent and is the active ingredient in Vaniqa brand 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 Food and Drug Administration (FDA) observed about 58% of women using it on facial hair had improvementVaniqa package insert.. 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 drynessHickman JG, Huber F, Palmisano M. Human dermal safety studies with eflornithine HCl 13.9% cream (Vaniqa), a novel treatment for excessive facial hair. Curr Med Res Opin 2001;16:235-44. PMID 11268707. . This corroborates unpublished data submitted to FDA showing about 2% of subjects discontinued use due to adverse reactions.

References

External links

Health in Africa | Antiprotozoal agents