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news.The National Institute on Alcohol Abuse and Alcoholism (NIAAA), part of the US National Institutes of Health's (NIH), has started a clinical trial of gabapentin enacarbil (Horizant) in extended-release tablets to treat patients with moderate to severe alcohol use disorder (AUD).
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In this sturdy, NIAAA is working in partnership with XenoPort, a biopharmaceutical company, which will supply gabapentin enacarbil.
Around 346 patients will be enrolled in this randomized, double blind, placebo-controlled clinical trial at ten sites across the US.
The trial will evaluate the safety and efficacy of 1200mg of Horizant, administered in two daily doses of 600mg each, compared with placebo to reduce drinking in subjects who report four or more symptoms of AUD.
During the trial, eligible patients will be given either Horizant or placebo for 26 weeks, to include one-week escalation, 24-week maintenance and one-week taper periods.
NIAAA director George Koob said: "Gabapentin has shown promising results in earlier clinical trials, and the development of new medications is an important component of our commitment to broaden the range of treatment options for people with AUD."
Gabapentin is already been widely prescribed to treat pain conditions and epilepsy.
Horizant contains gabapentin enacarbil, a prodrug of gabapentin that is converted to gabapentin in the body.
Gabapentin enacarbil is currently approved in the US to treat restless leg syndrome (RLS) and nerve pain caused by shingles.