OVATION to Collaborate With National Institute on Drug Abuse to Study Vigabatrin in Treating Cocaine Addiction
OVATION Pharmaceuticals, Inc. announced today that it has signed a five-year Cooperative Research and Development Agreement (CRADA) with the National Institute on Drug Abuse (NIDA), a division of the National Institutes of Health, to study the company’s novel anticonvulsant product, vigabatrin, for the treatment of cocaine and methamphetamine dependence. Vigabatrin is believed to block the euphoria associated with cocaine administration in humans and suppress craving by increasing brain levels of gamma-aminobutyric acid (GABA), an inhibitory transmitter in the brain.
“Substance abuse and addiction are major issues in our society today. There is a significant need for therapies that help to alleviate this growing national crisis,” said Jeffrey S. Aronin, President and Chief Executive Officer of OVATION Pharmaceuticals. “Our collaboration with NIDA builds on our extensive experience in CNS drug development and is consistent with our mission to address areas of significant unmet medical need.” OVATION is the vigabatrin IND holder and NDA applicant for vigabatrin.
Data from extensive animal models of addiction and two proof-of-concept studies in people with chronic cocaine and methamphetamine abuse have demonstrated the potential efficacy of vigabatrin in treating cocaine and methamphetamine addiction. By increasing GABA, vigabatrin may help to balance excitation of the brain with inhibition, which is believed to be the mechanism responsible for vigabatrin’s modulation of addictive behavior. OVATION and NIDA will collaborate under the CRADA to jointly design and implement preclinical studies as well as clinical trials to assess the efficacy and safety of vigabatrin in cocaine and methamphetamine abusers. Human trials will begin in early 2007.
The United States Office of National Drug Control Policy currently estimates that there are three million cocaine users and more than 300,000 methamphetamine users in the U.S. 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 infections diseases like HIV, tuberculosis and hepatitis. To date, there are no medications approved by the U.S. Food and Drug Administration for the treatment of cocaine or methamphetamine addiction. Current treatments focus on cognitive behavioral therapy and symptomatic treatments.
“Drug addiction remains a major public health problem in the United States and it is imperative that we continue to explore new treatment options,” said Frank Vocci, Ph.D., Director, Division of Pharmacotherapies and Medical Consequences of Drug Abuse (DPMCDA) at NIDA. “We are pleased to be partnering with OVATION to explore the potential of vigabatrin in treating cocaine and methamphetamine addiction.”
About Vigabatrin
Vigabatrin 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, vigabatrin crosses the blood-brain barrier and is active within the central nervous system. It is rapidly and completely absorbed following oral administration with relative bioavailability estimated at 100 percent. Vigabatrin is also being developed in the United States for refractory complex partial seizures and infantile spasms.
About OVATION Pharmaceuticals
OVATION is a biopharmaceutical company that develops and commercializes medicines for severely ill patients with unmet medical needs. 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 four new product 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 Scrip Award 2006 “Pharma Company of the Year” for small to mid-sized enterprises. More information about the company may be found at www.ovationpharma.com.