Xenoport, Inc. (XNPT) entered into a clinical trial collaboration agreement with the National Institute on Alcohol Abuse and Alcoholism (NIAAA) for a study that will evaluate HORIZANT (gabapentin enacarbil) extended-release tablets for treating patients with alcohol use disorder (AUD).
As per the agreement, Xenoport will supply clinical trial material and the NIAAA will be responsible for the other expenses pertaining to the study on HORIZANT. NIAAA will also conduct the study. Meanwhile, Xenoport will have the right to use the data generated from the study, which will be necessary to seek regulatory approvals for HORIZANT.
The randomized, double-blind, placebo-controlled study will enroll approximately 350 patients. The study, which will have a treatment period of six months, will evaluate the safety and efficacy of HORIZANT in patients suffering from AUD, but have refrained from alcohol at the beginning of treatment. The company intends to commence the study in the first half of 2015.
According to the press release issued by Xenoport, AUD affects nearly 17 million people in the U.S. Xenoport and the NIAAA plan to meet the Division of Anesthesia, Analgesia and Addiction Products of the FDA, in the fourth quarter of 2014 regarding the trial design. They also intend to discuss the probability of submitting a supplemental new drug application for HORIZANT for the maintenance of abstinence from heavy drinking of alcohol in AUD patients on the basis of the study results.
HORIZANT is currently approved in the US for the treatment of moderate-to-severe primary restless legs syndrome (RLS) as well as for the management of postherpetic neuralgia (PHN) in adults.
Xenoport is a Zacks Rank #4 (Sell) stock. Some better-ranked health care stocks include Amgen Inc. (AMGN), Cambrex Corp. (CBM) and China Biologic Products, Inc. (CBPO). All three carry a Zacks Rank #1 (Strong Buy).
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