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NORML: FDA Postpones Decision On Safety Of Controversial Cannabinoid Blocking Agent
04.05.07|NORML

US regulatory authorities announced that an independent Food and Drug Administration (FDA) advisory committee will hear testimony in June regarding whether the controversial cannabinoid receptor antagonist SR 141716A/Rimonabant is safe for human consumption. The agency had previously announced that it would decide by April 26, 2007, whether to grant US market approval for Rimonabant as a weight-loss drug.

Neither the FDA nor the drug's manufacturer, Sanofi-Aventis Pharmaceuticals, gave a reason for the postponement.

Under the FDA's revised timeline, the agency's Endocrinologic and Metabolic Drugs Advisory Committee will hear testimony regarding the drug's safety and efficacy on June 13, 2007. The FDA has previously denied Sanofi-Aventis Pharmaceuticals permission to market the drug in the US.

Rimonabant, marketed under the trade name Acomplia, recently received regulatory approval for sale in Europe as a prescription dietary aid. It is the first cannabinoid antagonist ever to be approved for human consumption.

Rimonabant blocks the natural binding of endogenous cannabinoids (as well as exogenous cannabinoids such as delta-9-THC, the psychoactive component of marijuana) to the neuronal CB1 receptors, causing users to lose their appetites. However, because the endocannabinoid receptor system is intricately involved in the regulation of a broad range of primary biological functions *-- including appetite, body temperature, mood regulation, blood pressure, bone density, reproduction, learning capacity, and motor coordination --* some experts are concerned that the long-term use of Rimonabant or similar drugs may eventually contribute to a host of significant adverse health effects.

In preclinical trials, newborn mice injected with Rimonabant refuse feeding and often die days after birth. Mice genetically bred to lack the CB1 receptor also suffer from numerous health defects such as cognitive decline, hypoalgesia, decreased locomotor activity, and increased mortality compared to healthy controls.

At least one published case study reports that daily use of the drug may have triggered neurological symptoms of multiple sclerosis in a volunteer with no known history of the disease. Mental health side effects, such as depression, are also commonly reported among volunteers administered Rimonabant.

In human trials, daily administration of Rimonabant is associated with lower blood sugar levels and weight loss compared to placebo. Sanofi is seeking to market the drug in the US under the trade name Zimulti.

For more information, please contact Paul Armentano, NORML Senior Policy Analyst, at (202) 483-5500.

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Donation links to NORML (The National Organization for the Reform of Marijuana Laws) | MPP (Marijuana Policy Project)

 

Buzzby

I don't know why people would fool around with vital biological systems just to lose weight. All they have to do is exercise a little will power and eat less. Watching reruns of Bush speeches should be sufficient to make them lose their appetites.

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Victor_vicious

There must be something I am missing here. If I read this right, the FDA is going to take the time to find out if they should allow the sale of a drug that would counteract the effects of Cannibis on appetites?? So far its only shown a few side effects including Multiple Sclorosis and depression?
Where is the logic? If you don't want to increase your appetite, just don't smoke the cannibis. Or if you do, learn to substitute healthy alternatives, when you get 'the munchies'.
We can't take the time or spend the money to study the effects of MJ, but we do have the time and money to study something to block the effects of MJ.
For years, the drug companies have benn trying to 'make' a substitute for MJ so they can control and profit from it and haven't been able to accomplish that. So what are they saying now? We can't do better than the cannibis can, but if you do smoke, be sure and contact your health professional to see if our new wonder drug can limit the side effects, like an increase in appetite.
You risk getting depressed etc. Whats the cure for that drug? smoke another joint? And they want to put alcohol and tobacco under the control of the FDA, where they belong? The mind boggles......

Buzzby

Counteracting the effects of cannabis is not the primary purpose of this new drug. It's purpose is to counteract the effects of endocannabinoids which happen to use the same CB1 receptors as THC. The endocannabinoids have the same appetite-stimulating effect as THC.

dedbr

FDA? Doesn't that stand for fool's, dopes and assholes?

This little piece of info brought to you from the same folk's that said herb had no medical use. I trust political appointee's as far as I can throw 'em..........

Over my lifetime the U.S. population has been used as lab rats for the drug companies......and if big drug is sued, they pay two or three percent of the profits in lawsuits and still walk away free and clear.......

And life goes on.........


Some Where In Ded Land.........

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"Don't talk to me of pacts. There are no pacts between lions and men. Wolves and lambs can enjoy no meeting of the minds, they are all bent on hating each other to the death."

Homer

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Victor_vicious

Ok, so where to the endocannabinoids come from? Are they nturally produced in the body? VV

Buzzby

Do a Google search on "endocannabinoids". You'll learn some interesting stuff.