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.