Did some reading on Rimonabant today - this is a weight loss drug developed by Sanofi-Aventis. In 2007 it was denied approval by FDA committee because SA had failed to demonstrate safety (in response to FDA questions). It was approved in Europe (as Acomplia) and was on the market from 2006 to 2008, then the European Medicines Agency recommended that doctors not prescribe the drug due to the "risk of serious psychiatric problems" and the drug was suspended.

Looking a the FDA briefing (link below), this stuff makes Lorcaserin look fantastic. "Specifically, 9% of rimonabant 20-mg treated subjects vs. 5% of placebo treated subjects reported symptoms of depression (depressed mood; depression; depressive symptom; or major depression)."

http://www.fda.gov/ohrms/dockets/ac/07/b...

I was searching on this to get perspective on approval factors and was also surprised to see how many tainted weight loss pills that contain "undeclared, active pharmaceutical ingredients" in dietary supplement formulations (links below). It seems to me that Lorc might also offer certain advantages as a new, safer treatment that could make these bogus products less marketable.

http://www.fda.gov/Drugs/ResourcesForYou...

http://www.fda.gov/Safety/MedWatch/Safet...

This is what we're up against folks - the stigma of the previous failures. It also clearly shows why it boils down to safety first, efficacy second. Once the *MILD and SAFE* message gets through to marketing partners, things could change rapidly as many shorts try to fit through a very small door.
later,
d320