Acomplia (Rimonabant,
prescription) - Shot Down by FDA
The latest
new prescription anti-obesity drug that was closest to U.S. market launch
was Rimonabant, brand name Acomplia or Zimulti. This is a drug
under development by Sanofi-Aventis. Other drug companies are developing
their own compounds that work on the same brain receptors, but
Sanofi-Aventis is the first to perform clinical trials.
An FDA
panel met in July and unanimously rejected Acomplia (called Zimulti in the
U.S.), on concerns that it increases the number of
psychiatric problems such as depression and suicidal thoughts. The
drug does remain approved in the European Union, though it can't be
prescribed to patients suffering from depression.
It
is the only endocannabinoid receptor antagonist in clinical development and
this offers a unique therapeutic approach to appetite control and weight
reduction. The drug also has potential as a treatment for smoking cessation.
Acomplia may be bought in some pharmacies across the Mexican border. Mexican
prices for the diet drug reportedly are in the $100 range for 28 pills,
making purchases in Mexican border towns, if a visitor either lives just
across the border or is in Mexico on holiday, a less expensive option than
purchasing the diet pills by mail order from Europe. In light of the
potential side effects, however, using the drug at all may be risky.
The
FDA has repeatedly warned that many “brand-name” drugs purchased in Mexican
border pharmacies (even those in perfect packaging) have been found to be
counterfeit. Surprisingly low prices for drugs should be treated with
particular suspicion.
The
importation of “unapproved new drugs” – any drugs that have not received FDA
approval, as is the case with Acomplia, is prohibited.
Some potential medications have proved effective in the first six months of
treatment only to lose effectiveness as people develop resistance to
treatment. Long-term safety is a major concern. In the U.S., the FDA usually
requires two years of safety data before approving anti-obesity drugs.
Side effects associated
with Rimonabant in trials have included depression, anxiety and nausea.
About 1 in 8 patients taking the drug dropped out of the study due to side
effects, compared to 7% in the placebo group. Medical authorities urge
caution and not to get too excited about it yet. First, Rimonabant is the
first of a new class of drugs targeting the endocannabinoid system, which
helps regulate pleasure, relaxation and pain tolerance. We still don’t have
a good idea of what happens when we interfere with this system on a
long-term basis.