XenoPort to collaborate with the NIAAA for Horizant trial

Neurological biopharma specialist XenoPort (Nasdaq: XNPT) is to enter into an agreement with the National Institute on Alcohol Abuse and Alcoholism (NIAAA) to conduct a clinical trial of its drug Horizant (gabapentin enacarbil) in the treatment of alcohol use disorder.

XenoPort will provide clinical trial material and the NIAAA will conduct and pay all other expenses associated with the trial. XenoPort will then have access to study results generated through the trial to support potential regulatory filings for Horizant.

The study is planned to be a randomized, double-blind placebo-controlled trial of the safety and efficacy of Horizant in patients with alcohol use disorder who are abstinent when treatment begins. The study is planned for the first half of 2015, with a treatment period of six months, enrolling around 350 patients. XenoPort and the NIAAA are planning to meet with the US Food and Drug Administration division of anesthesia, analgesia and addiction products in the fourth quarter of 2014 to discuss trial design, and the potential for using the results of the trial as the basis for a supplemental new drug application submission for Horizant for the maintenance of abstinence from heavy alcohol consumption in alcohol use disorder patients.