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Article: Avigen initiates opioid withdrawal trial

Avigen, Inc. (Nasdaq: AVGN), a biopharmaceutical company innovating therapeutics for neurological care, recently announced the launch of an exploratory study of the company's pipeline product, AV411 (ibudilast), for the treatment of opioid withdrawal symptoms. The study is largely funded by the National Institute on Drug Abuse (NIDA) and will be run jointly by the New York State Psychiatric Institute (NYSPI) and Columbia University.

"We are excited to participate in a study of this stature in partnership with NIDA, NYSPI and Columbia," said Kenneth Chahine, Ph.D., J.D., Avigen's President and Chief Executive Officer. "This trial builds upon our research of AV411's unique glial-attenuating properties and will complement Avigen's clinical studies of AV411 to treat neuropathic pain. We believe both of these exploratory paths may show that AV411 can become a breakthrough therapy for these disabling disorders."

"NIDA has chosen to fund this study based on its review of Avigen's research and its interest in the role of glial-attenuation as a novel way to treat opioid withdrawal symptoms, a common result of opioid abuse that can hinder recovery," said Frank J. Vocci, Ph.D., Director of the Division of Pharmacotherapies and Medical Consequences of Drug Abuse at the National Institute on Drug Abuse (NIDA). "This is truly an unmet medical need in this country. The nonmedical use or abuse of prescription drugs - primarily opioids - is a serious and growing public health problem. In fact, an estimated 33 million people have used prescription drugs for nonmedical reasons in their lifetimes - approximately 15 percent of the U.S. adult population."

The clinical study will assess the safety and tolerability of AV411, a non-opioid compound, when administered twice daily to heroin addicts who are maintained on morphine, a commonly used opiate analgesic drug, over a 14-day period. The trial will assess preliminary efficacy of AV411 for reducing the symptoms of opioid withdrawal.

"In preclinical studies, opioid treatment induces brain glial cell activation that correlates with both opioid tolerance and dependence," explained the study's principle investigator, Sandra D. Comer, Ph.D., Associate Professor of Clinical Neurobiology at NYSPI and Columbia University. "Preclinical studies have shown that AV411 can attenuate the behavioral signs of opioid withdrawal and corresponding glial cell activation without conferring adverse side effects. My research team and our partners are eager to confirm these findings in humans and help move this potentially important new medicine through clinical development."

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