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ADial Pharmaceuticals Announces Agreement With FDA For Phase III Trial Of AD04 For Alcohol Use Disorder In Patients Of Targeted Genotypes
Date:4/18/2013

s 42 million people in the U.S. alone are afflicted by an alcohol disorder. The Centers for Disease Control ("CDC") has reported that alcohol disorders cost the U.S. economy more than $200 billion annually, with heavy drinking accounting for greater than 75% of the social and health related costs. Despite this, fewer than 5% of patients with AUD are estimated to have been diagnosed and significantly fewer receive meaningful treatment. AUD is characterized by an urge to consume alcohol and an inability to control the levels of consumption. Both acute and chronic consumption of high levels of alcohol are associated with negative social and health consequences. In the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) being published in May 2013, AUD replaces the disease states previously defined as alcohol abuse and alcohol dependence.

About AD04

AD04 is being developed as a treatment for alcohol use disorder in patients of select genotypes. AD04 is a serotonin-3 (5HT3) antagonist that is believed to interrupt the reinforcing effects of alcohol, and thus reduces the urge to drink. Such reinforcing effects are thought to be exaggerated in patients that have certain mutations of the genes that control serotonin function in the brain, and these are the patients targeted for treatment with AD04. AD04 contains an ultra-low dose of the active ingredient ondansetron, which is currently marketed as an anti-emetic for post-operative and post-chemotherapy nausea. Doses effective for treating alcohol addiction are well below those used to treat emesis. Clinical and non-clinical experience to date suggest that higher doses like those used for the treatment of emesis may have reduced efficacy for treating addiction and additional safety risks associated with their chronic use as would be required for treatment of addiction.

ADial has patents covering the use of ondansetron in patients with the targeted genot
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SOURCE ADial Pharmaceuticals, LLC
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