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Published Data Demonstrate Arena Pharmaceuticals' Lorcaserin Has Low Abuse Potential
Date:12/10/2009

SAN DIEGO, Dec. 10, 2009 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported that positive data from a clinical trial evaluating the abuse potential of lorcaserin were presented in a poster session at the 48th Annual Meeting of the American College of Neuropsychopharmacology. Data from the trial demonstrate that the risk for abuse associated with lorcaserin is very low.

"Human abuse liability studies of the type done by Arena provide critical data to the FDA and DEA for decisions about any post-marketing scheduling and control under the Controlled Substance Act," said Edward M. Sellers, M.D., Ph.D., Vice President of Kendle International Inc., and Principal Investigator.

Investigational drugs that act through mechanisms in the brain are generally required to undergo an evaluation to determine abuse potential. This determination will be made by the US Drug Enforcement Administration (DEA), with input from the US Food and Drug Administration (FDA), as part of the regulatory review process. Lorcaserin was studied in a standard paradigm at doses well above the intended therapeutic dose of 10 mg twice daily. The clinical trial compared the relative abuse potential of lorcaserin against three comparators: placebo, zolpidem (a schedule IV controlled substance) and ketamine (a schedule III controlled substance).

The trial was a randomized, placebo-controlled, double-blind, seven-way crossover trial conducted in 35 healthy male and female recreational drug users. Subjects received single doses of lorcaserin (20 mg, 40 mg and 60 mg), zolpidem (15 mg and 30 mg), ketamine (100 mg) and placebo in a blinded fashion. Following dosing, subjects completed tests that assessed their subjective states and the drugs' effects (both positive and negative). The primary endpoint was derived from the scor
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SOURCE Arena Pharmaceuticals, Inc.
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