OVATION Receives Fast Track Designation For Sabril(R) To Treat Cocaine And Methamphetamine Dependence

Main Category: Alcohol / Addiction / Illegal Drugs
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 24 Jan 2008 - 3:00 PDT

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OVATION Pharmaceuticals, Inc. announced that Sabril(R) (vigabatrin) has received Fast Track designation from the U.S. Food and Drug Administration (FDA), potentially expediting development of this novel compound that is being evaluated for the treatment of cocaine and methamphetamine dependence. Fast Track status indicates that the FDA has recognized that Sabril is intended for the treatment of a serious or life-threatening condition for which there are no available treatments and which demonstrates the potential to address unmet medical needs.

"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, Pharmacovigilance, and Clinical Quality Assurance. "We believe that 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 estimates that there are over one million cocaine and methamphetamine users each year in the United States who seek help to treat their addiction. Untreated stimulant dependence results in significant increases in health, social service and criminal justice costs to society and is a major contributor to the spread of infectious diseases like HIV, tuberculosis and hepatitis.

To date, there are no medications approved by the FDA for the treatment of cocaine or methamphetamine addiction. Current treatments focus on cognitive behavioral therapy and symptomatic treatments. It is believed that Sabril may block the euphoria associated with cocaine administration in humans and may suppress craving by increasing brain levels of gamma-aminobutyric acid (GABA), an inhibitory transmitter in the brain. OVATION is collaborating with the National Institute on Drug Abuse on Phase II studies to evaluate the safety of Sabril in the treatment of patients with cocaine and methamphetamine addiction.

The FDA established the Fast Track designation to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions so that these products can reach approval more rapidly. To receive Fast Track designation, the product must address a serious unmet medical condition, and be supported by strong results from preclinical or clinical testing demonstrating the product potential.

About Sabril® (vigabatrin)

Sabril is also being developed by OVATION in the United States for refractory complex partial seizures and infantile spasms. It was synthesized in 1974 as the first designer drug for epilepsy. It is an irreversible GABA-transaminase inhibitor that produces a two- to three-fold increase in brain levels of GABA, a substance in the brain that acts to inhibit epileptic seizures. Following oral administration, Sabril crosses the blood-brain barrier and is active within the central nervous system. It is rapidly and completely absorbed following oral administration with high bioavailability. Sabril is a registered U.S. trademark of OVATION.

About OVATION Pharmaceuticals

OVATION is a fast-growing biopharmaceutical company that develops, manufactures and markets medically necessary therapies to satisfy unmet medical needs for patients with severe illnesses. Headquartered in Deerfield, Ill., with products available in more than 85 countries, OVATION is committed to having a significant impact on patients' lives through its focus on central nervous system (CNS), hematology/oncology, and hospital-based therapies. The five new launches the company expects over the next five years will be fueled by its late-stage CNS pipeline, which is one of the most robust in the industry. OVATION has been recognized for excellence in the global pharmaceutical and biotechnology industries with the 2006 and 2007 "Pharma Company of the Year" award from Scrip magazine for small to mid-sized enterprises.

OVATION Pharmaceuticals

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