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OVATION to Collaborate with National Institute on Drug Abuse to Study Vigabatrin in Treating Cocaine Addiction.


DEERFIELD, Ill. -- OVATION Pharmaceuticals, Inc. announced today that it has signed a five-year Cooperative Research and Development Agreement “CRADA” redirects here. For other uses, see CRADA (disambiguation).

A Cooperative Research and Development Agreement (CRADA) is an agreement between a government agency and a private company to work together.
 (CRADA CRADA Cooperative Research And Development Agreement ) with the National Institute on Drug Abuse The National Institute on Drug Abuse (NIDA) is a United States federal-government research institute whose mission is to "lead the Nation in bringing the power of science to bear on drug abuse and addiction.  (NIDA), a division of the National Institutes of Health, to study the company's novel anticonvulsant anticonvulsant /an·ti·con·vul·sant/ (-kon-vul´sant) inhibiting convulsions, or an agent that does this.

an·ti·con·vul·sant
n.
A drug that prevents or relieves convulsions.
 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 GABA ?.

GABA
abbr.
gamma-aminobutyric acid


GABA (gamma-aminobutyric acid)
A neurotransmitter that slows down the activity of nerve cells in the brain.
), 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 See Continuous net settlement.

CNS

See continuous net settlement (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 (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any  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 The Office of National Drug Control Policy (ONDCP) was established by the National Narcotics Leadership Act of 1988 (21 U.S.C.A. § 1501 et seq.) and began operations in January 1989.  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 HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. , 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 cognitive behavioral therapy
n.
A highly structured psychotherapeutic method used to alter distorted attitudes and problem behavior by identifying and replacing negative inaccurate thoughts and changing the rewards for behaviors.
 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 transaminase /trans·am·i·nase/ (-am´i-nas) aminotransferase.

trans·am·i·nase
n.
See aminotransferase.
 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.
COPYRIGHT 2007 Business Wire
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Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Jan 23, 2007
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