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XenoPort, Inc. and the National Institute on Alcohol Abuse & Alcoholism Announce Clinical Trial Agreement to Study Horizant as Potential Treatment for Alcohol Use Disorder
Sep 9 14
XenoPort, Inc. and the National Institute on Alcohol Abuse and Alcoholism announced that they have entered into an agreement to conduct a clinical trial of HORIZANT(R) (gabapentin enacarbil) Extended-Release Tablets as a potential treatment for alcohol use disorder (AUD). Under the terms of the agreement, XenoPort will supply clinical trial material and the NIAAA will conduct and pay all other expenses associated with the proposed clinical trial of HORIZANT. XenoPort will have access to study results generated under the proposed clinical trial to support potential regulatory filings for HORIZANT. The study is planned to be a randomized, double-blind, placebo-controlled clinical trial of the safety and efficacy of HORIZANT in patients who have AUD but are abstinent at treatment initiation. The study is expected to have a treatment period of six months and to enroll approximately 350 patients beginning in the first half of 2015. XenoPort and the NIAAA are planning to meet with the U.S. Food and Drug Administration (FDA) Division of Anesthesia, Analgesia and Addiction Products in the fourth quarter of 2014 to discuss the trial design and the possibility of utilizing the results of this trial as the basis for a potential supplemental new drug application (sNDA) submission for HORIZANT for the maintenance of abstinence from heavy drinking of alcohol in patients with AUD.
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