First New Treatment for Alcoholism in Ten Years, Now Available Campral(R) (Acamprosate Calcium) Delayed-Release Tablets
January 11 2005 - 8:01AM
PR Newswire (US)
First New Treatment for Alcoholism in Ten Years, Now Available
Campral(R) (Acamprosate Calcium) Delayed-Release Tablets NEW YORK,
Jan. 11 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE:FRX) announced today that Campral(R) (acamprosate calcium)
Delayed- Release Tablets are now available to physicians, patients
and pharmacies nationwide. Campral was approved by the U.S. Food
and Drug Administration (FDA) on July 29, 2004 for the maintenance
of abstinence from alcohol in patients with alcohol dependence who
are abstinent at treatment initiation. Treatment with Campral
should be part of a comprehensive management program that includes
psychosocial support. The approval of Campral was the first in
nearly ten years of a treatment for alcohol dependence. "We believe
that Campral, in combination with psychosocial support, sets a new
standard for treating the chronic disease of alcoholism," said
Howard Solomon, Chairman and Chief Executive Officer of Forest
Laboratories. "Forest is committed to providing an effective and
safe drug therapy to help the millions of Americans struggling with
alcohol-dependence to maintain abstinence." Campral and Complete
Abstinence "A major treatment goal for alcohol dependence is to
increase rates of abstinence," said Barbara Mason, Ph.D., Professor
of Neuropharmacology, Co- Director of The Pearson Center for
Alcoholism and Addiction Research, The Scripps Research Institute.
"Campral, when used in combination with psychosocial support, can
help committed patients reach this goal because it is thought to
help restore the brain's chemical balance that has been disrupted
by long-term excessive drinking." The mechanism of action of
Campral in maintenance of alcohol abstinence is not completely
understood. Chronic alcohol exposure is hypothesized to alter the
normal balance between neuronal excitation and inhibition.(1)
Campral interacts with neurotransmitter systems and is hypothesized
to restore the normal balance.(1) This mechanism of action is
different from that ascribed to currently available medications,
which either block the "high" associated with alcohol(2) or induce
vomiting if alcohol is ingested.(3) FDA approval of Campral is
based primarily on the Agency's review of short and long-term
efficacy and safety data from double-blind, placebo-controlled
trials. In three of the trials, which lasted from 90 days to 360
days, Campral plus psychosocial therapy proved superior to placebo
plus psychosocial therapy in maintaining abstinence, as indicated
by a greater percentage of subjects being assessed as continuously
abstinent throughout treatment.(1) In a fourth study, the
Campral-treated group failed to show a difference on the primary
efficacy endpoint, cumulative abstinence duration. In this trial,
patients were not required to be abstinent prior to randomization
as required in the positive studies.(1) In the clinical trial
program, side effects for Campral were generally mild with the most
frequently reported side effect being diarrhea.(4) Campral is
contraindicated in patients with severe renal impairment
(creatinine clearance less than or equal to 30 mL/min) and requires
a dose reduction in patients with moderate renal impairment
(creatinine clearance of 30-50 mL/min).(1) The recommended dose of
Campral is two 333 mg tablets taken three times daily.(1) Treatment
with Campral should be initiated as soon as possible after the
period of alcohol withdrawal, when the patient has achieved
abstinence, and should be maintained if the patient relapses.(1)
Campral was developed by Merck Sante s.a.s., subsidiary of Merck
KGaA of Darmstadt, Germany, and licensed to Forest Laboratories for
the United States. Interested parties can get more information on
Campral and obtain the prescribing information by visiting
http://www.campral.com/ or by calling 800- 678-1605. About
Alcoholism Nearly 8 million Americans are alcohol dependent(5), but
only 2.4 million have been diagnosed(6) with the disease and just
139,000 receive medication to treat it.(7) Left untreated,
alcoholism increases the risk for heart disease, liver disease,
infectious disease, and cancer.(8) About Forest Laboratories and
Its Products Forest Laboratories' growing line of products
includes: Lexapro(R) (escitalopram oxalate), an SSRI antidepressant
indicated for the initial and maintenance treatment of major
depressive disorder and for generalized anxiety disorder in adults;
Namenda(R) (memantine HCl), an N-methyl-D-aspartate (NMDA)-receptor
antagonist indicated for the treatment of moderate to severe
Alzheimer's disease; Celexa(R) (citalopram HBr), an antidepressant
for adults; Benicar(R) * (olmesartan medoxomil), an angiotensin
receptor blocker indicated for the treatment of hypertension;
Benicar HCT(TM) (olmesartan medoxomil hydrochlorothiazide), an
angiotensin receptor blocker and diuretic combination product
indicated for the second-line treatment of hypertension; Campral(R)
* (acamprosate calcium), a glutamate receptor modulator, indicated
for the maintenance of abstinence from alcohol in patients with
alcohol dependence who are abstinent at treatment initiation in
combination with psychosocial support; Combunox(TM) (Oxycodone HCl
and Ibuprofen) an opioid and NSAID combination indicated for the
short-term management of acute, moderate to severe pain expected to
be available in the U.S. early 2005. Except for the historical
information contained herein, this release contains
"forward-looking statements" within the meaning of the Private
Securities Reform Act of 1995. These statements are subject to
risks and uncertainties that affect our business, including risk
factors listed from time to time in the Company's SEC reports,
including the Company's Annual Report on Form 10-K for the fiscal
year ended March 31, 2004, and on form 10-Q for the period ended
June 30, 2004, and September 30, 2004. Actual results may differ
materially from those projected. * Benicar(R) is a registered
trademark of Sankyo Pharma, Inc., Campral(R) is a registered
trademark under license from Merck Sante s.a.s., subsidiary of
Merck KGaA, Darmstadt, Germany. (1) Campral(R) (acamprosate
calcium) Delayed-Release Tablets Prescribing Information, Forest
Laboratories, Inc., St.Louis, Mo, 2004. Pg. 1. (2) Garbutt, J.C.;
West, S.L.; Carey, T.S.; Lohr, K.N.; Crews, F.T. Pharmacological
treatment of alcohol dependence: a review of the evidence. JAMA.
1999;281:1318-1325. (3) Solhkhah R, M.D.; Wilens T, M.D.
Pharmacotherapy of Adolescent Alcohol and Other Drug Use Disorders.
Alcohol Health and Research World.1998; 22(2);122. (4) Data on
file, Forest Laboratories, Inc. (5) Grant, B.F.; Dawson, D.A.;
Stinson, F.S.; Chou, S.P.; Dufour, M.C.; Pickering, R. The 12-month
prevalence and trends in DSM-IV alcohol abuse and dependence:
United States, 1991-1992 and 2001-2002. Drug and Alcohol Dependence
2004; (74); 229. (6) Data on file, Forest Laboratories, Inc. (7)
Verispan data on file, Forest Laboratories, Inc. (8) Bagnardi V;
Blangiardo M; Vecchia C, et al. Alcohol consumption and the risk of
cancer. Alcohol Research and Health. 2001; 25(4); 263-270.
DATASOURCE: Forest Laboratories CONTACT: Charles E. Triano, Vice
President, Investor Relations of Forest Laboratories,
+1-212-224-6714, or Web site: http://www.campral.com/
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