Published Data Demonstrate Arena Pharmaceuticals' Lorcaserin Has Low Abuse Potential
- Data Presented at the 48th Annual Meeting of the American College of Neuropsychopharmacology -
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 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.
About Lorcaserin
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.
Forward-Looking Statements
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 Partners Jack Lief David Schull, President President and CEO david.schull@russopartnersllc.com 212.845.4271 Cindy McGee Manager, IR and Corporate Anthony J. Russo, Ph.D., CEO Communications tony.russo@russopartnersllc.com cmcgee@arenapharm.com 212.845.4251 858.967.1646
Source: Arena Pharmaceuticals, Inc.
CONTACT: Jack Lief, President and CEO or Cindy McGee, Manager,
IR and
Corporate Communications, cmcgee@arenapharm.com, both
of Arena
Pharmaceuticals, Inc., +1-858-967-1646; or Media, David Schull,
President,
+1-212-845-4271, david.schull@russopartnersllc.com,
or Anthony J. Russo,
Ph.D., CEO, +1-212-845-4251, tony.russo@russopartnersllc.com,
both of Russo
Partners for Arena Pharmaceuticals, Inc.
Web Site: http://www.arenapharm.com/
Posted: December 2009
