SAN DIEGO, Dec. 10, 2009 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 scores on a "drug liking" scale.
The subjects reported neutral "drug liking" scores for placebo and positive "drug liking" scores for zolpidem and ketamine, which confirmed study validity. The subjective effects of the 20 mg lorcaserin dose were similar to those of placebo. "Drug liking" was significantly lower for the 40 mg and 60 mg lorcaserin doses as compared to zolpidem and ketamine, and subjects demonstrated significant disliking of these supratherapeutic doses of lorcaserin compared to placebo. The subjects' willingness to take lorcaserin again for recreational purposes was significantly lower for 40 mg and 60 mg doses as compared to placebo.
Data from the trial demonstrate that the risk for abuse associated with lorcaserin is very low and less than that of zolpidem or ketamine. At the supratherapeutic doses, lorcaserin was associated with distinct, primarily negative, subjective effects. Although the majority of subjects who took lorcaserin at the supratherapeutic doses in this trial reported adverse events, most often headache, only two subjects withdrew from the trial because of an adverse event.
Lorcaserin is a novel single agent that represents the first in a new class of selective serotonin 2C receptor agonists. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area involved in the control of appetite and metabolism. Stimulation of this receptor is strongly associated with feeding behavior and satiety. Arena has patents that cover lorcaserin in the US and other jurisdictions, which in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.
About Arena Pharmaceuticals
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena's most advanced drug candidate, lorcaserin, is being investigated in a Phase 3 clinical trial program for weight management. Arena has a broad pipeline of novel compounds targeting G protein-coupled receptors, an important class of validated drug targets, which includes compounds being evaluated independently and with partners, including Merck & Co., Inc., and Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Arena Pharmaceuticals® and Arena® are registered service marks of the company. "APD" is an abbreviation for Arena Pharmaceuticals Development.
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the risk for abuse associated with lorcaserin; the use of abuse liability studies by the FDA and DEA and the significance of such studies in determining post-marketing scheduling and control; the development, advancement, therapeutic indication and use, tolerability, safety, selectivity and efficacy of lorcaserin; lorcaserin's patent coverage; and Arena's strategy, internal and partnered programs, and ability to develop compounds and commercialize drugs. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, regulatory authorities may disagree with the assessment of the abuse and other study results or find data from Arena's clinical trials and studies not sufficient for regulatory approval; the timing, success and cost of Arena's lorcaserin program and other of its research and development programs; the timing and ability of Arena to receive regulatory approval for its drug candidates; results of clinical trials or preclinical studies may not be predictive of future results; clinical trials and studies may not proceed at the time or in the manner Arena expects or at all; Arena's ability to partner or commercialize lorcaserin or other of its compounds or programs; Arena's ability to obtain additional funds; Arena's ability to obtain and defend its patents; and the timing and receipt of payments and fees, if any, from Arena's collaborators. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Contact: Arena Pharmaceuticals, Inc. Media Contact: Russo PartnersJack Lief David Schull, PresidentPresident and CEO [email protected]
212.845.4271Cindy McGeeManager, IR and Corporate Anthony J. Russo, Ph.D., CEOCommunications [email protected]
SOURCE Arena Pharmaceuticals, Inc.