FDA Fast-Tracks Sabril as Anti-Craving Drug
The U.S. Food and Drug Administration has placed the drug vigabatrin, to be marketed under the name Sabril, on a fast track for approval for the treatment of cocaine and methamphetamine addiction. The drug is already approved as an anticonvulsant used for the treatment of seizures and infantile spasms.
Sabril works for cocaine and meth users by reducing the cravings for the drugs. If they do use meth or cocaine, Sabril blocks the euphoria usually experienced with their use, according to Ovation Pharmaceuticals, manufacturer of the drug.
It works by increasing the level of a neurotransmitter called gamma-aminobutyric acid, researchers say.
More Research Studies Planned
Although data is available from animal testing and two small-scale, early-stage studies with humans, the FDA is "fast tracking" Sabril for approval, because it has already been found safe for use in treating seizures.
The drug is already being tested by National Institute on Drug Abuse scientists in Phase II studies to evaluate its safety and Phase III trials are expected to begin by the end of 2009. Phase III is the final testing stage before FDA approval.
If it is approved, it will be the first drug on the market approved for the treatment of cocaine and methamphetamine dependence.
Related Information:
Photo: Ovation PharmaceuticalsSource: Chicago Sun-Times. FDA fast-tracks first cocaine, meth addiction fighter January 22, 2008.


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