Ovation’s Sabril treatment for drug addiction gets fast tracked by FDA

DEERFIELD, Ill. The Food and Drug Administration has granted Ovation Pharmaceuticals drug vigabatrin, brand name Sabril, a “fast track” designation in an effort to speed up the process for market approval, according to published reports.

The drug blocks the cravings and euphoria associated with cocaine and methamphetamine use. It would be the first approved drug for the treatment of the addictions.

Data from animal testing and two small-scale early-stage studies in people with chronic cocaine and meth addiction have found that when given Sabril, cocaine and meth users no longer have a craving for the drugs, and if the drugs are taken, the users have no euphoria related to taking them, executives have said.

Ovation is collaborating with the National Institute on Drug Abuse on Phase II studies to evaluate the safety of the drug. Phase III trials are expected to be launched by the end of next year.