FDA fast-tracks first cocaine, meth addiction fighter

[via the chicago sun-times]

Deerfield-based Ovation Pharmaceuticals said Tuesday its drug vigabatrin, being developed to treat cocaine and methamphetamine dependence, has landed “fast track” designation from U.S. regulators potentially speeding up the process for market approval.

The drug would be the first approved by the U.S. Food and Drug Administration for treatment of the addictions.

The anticonvulsant drug, to be marketed under the brand name Sabril, is believed to block the craving and euphoria associated with cocaine and meth use. It is thought to work by increasing brain levels of so-called gamma-aminobutyric acid, a transmitter that inhibits certain activity in the brain.

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.

“We are pleased that the FDA has recognized the significant need for effective treatment options to address stimulant addiction, which is a major public health problem,” said Dr. Tim Cunniff, Ovation Vice President, Global Regulatory Affairs.

“We believe this Fast Track designation for Sabril will accelerate our efforts to bring to market a treatment option for the hundreds of thousands of people who suffer from dependence on cocaine and methamphetamine.”

A 2006 survey sponsored by the Substance Abuse and Mental Health Services Administration estimated there are more than 1 million cocaine and meth users each year in the United States alone who seek help to treat their addiction.

Ovation late last year filed for U.S. regulatory approval of Sabril to treat seizures and infantile spasms.

Ovation develops drugs to meet unmet medical needs for patients with severe illnesses.