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News »November 2006

Why Is Acomplia Being Stalled, Questions Leading Researcher

November 30, 2006

Why is the pill still being anticipated, when it's all set for release. According to one of the lead researchers in the largest North American clinical trial, he has stated in a CBS interview on November 29th that he has no idea for the reason of delay by the U.S. Food and Drug Administration.

Dr. Louis J.Aronne who is one of the most enthusiastic supporters of Acomplia was questioned by an interviewer at CBS as what are the main concerns regarding the delay of the release of the weight loss drug by FDA and why hasn't it yet approved it.

Aronne replied that he couldn't say the reason and nobody knows what FDA looks into, as all that is a secret.

Along with two Sanofi Aventis researchers Aronne director of the comprehensive weight control program at New York Presbyterian Hospital was one of the three doctors listed who reported in the journal of the American Medical Association on their analysis of the RIO North America Trial.

The data which was presented from these studies formed the main material which Sanofi presented to the FDA for seeking a market for its release.

What struck a few observers was that Aronne not knowing anything regarding FDA's statement since Sanofi clearly knew what issues FDA was looking at.

Previous to Acomplia no drug has been proved to work on the cannobinoid receptors in the brain and the question which is asked often is about Acomplia's side effects. Aronne was non - committed of the concerns regarding the side effects of Acomplia.

Aronne also said, the side effects like dizziness, nausea, anxiety, depressed mood were seen among the individuals but were uncommon compared to other treatments they have had in the past.

Aronne also stated that all the side effects go away when the pill is stopped. They found it a very tolerable statement.

 



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