- Researcher Awarded ASAM's Highest Honor for Scientific Merit -
DALLAS, April 15, 2005 /PRNewswire-FirstCall via COMTEX/ -- Forest Laboratories, Inc.
(NYSE: FRX) today announced results of two analyses of several studies
demonstrating that Campral(R) (acamprosate calcium) Delayed-Release Tablets is
safe and well-tolerated in the long-term treatment of alcohol dependence. The
report(1), which was presented today at the 36th Annual Medical-Scientific
Conference of the American Society of Addiction Medicine (ASAM), found Campral
to be safe and well tolerated in studies up to one year, even in patients
taking other drugs such as antidepressants and analgesics.(1)
"These data are important because they show that Campral is safe for
alcohol-dependent patients and even in those who may be taking other
medications," said investigator Richard N. Rosenthal, MD, Professor of
Clinical Psychiatry, Columbia University College of Physicians and Surgeons.
"Unlike older treatments for alcohol dependence, Campral is not metabolized
through the liver. Its favorable long-term safety profile makes it an
attractive new option to help reduce relapse in patients committed to staying
abstinent from alcohol."
The abstract "Acamprosate is Safe and Well-Tolerated in the Long-Term
Treatment of Alcohol Dependence" received this year's ASAM Medical-Scientific
Program Committee Award for having the highest rating for scientific merit.
The ASAM Conference Program Committee reviewers grant this award to one
abstract each year. The award is based on the presentation of new ideas or
findings of importance to the field of addiction medicine, the methodology
used and clarity of presentation.
Results
The abstract contained data from two key analyses. The first analysis
assessed five year-long, double-blind, placebo-controlled studies (n=1681) to
determine long-term safety and tolerability of Campral in alcohol-dependent
patients, 16 to 70 years of age.(1) In this five-study analysis, patients were
randomized to receive either Campral 1332 mg/day or Campral 1998 mg/day with
counseling, or placebo plus counseling. A second analysis reviewed four
long-term studies and six short term studies (n=3395). The aim of this second
analysis was to evaluate the impact of concomitant medications on the
tolerability profile of Campral versus placebo.
In the first analysis, the overall incidence of spontaneously reported
adverse events was similar between the Campral 1998 mg/day group and the
placebo group.(1) Rates of adverse events for the combined Campral group (1998
mg and 1332 mg) were higher than placebo (59 percent vs 52 percent;
P<0.050).(1) Diarrhea was the only adverse event reported at higher rates than
placebo, occurring in 10 percent of both Campral groups and 6 percent of the
placebo group (P<0.010).(1) The 1998 mg dose is the only dose approved by the
FDA.(2)
In the second analysis, the incidence of adverse events in patients
treated with Campral concomitantly with medications such as antidepressants,
anxiolytics, sedatives, hypnotics, and analgesics, was comparable to that of
patients taking placebo with these concomitant medications.(1)
Overall, in this study, Campral was found to be safe and well-tolerated in
the long-term treatment of alcohol dependence.(1)
About Campral
Campral (acamprosate calcium) Delayed-Release Tablets are FDA-approved for
the maintenance of abstinence from alcohol in patients with alcohol dependence
who are abstinent at treatment initiation.(2) Treatment with Campral should be
part of a comprehensive management program that includes psychosocial
support.(2)
In clinical trials, patients taking Campral demonstrated a higher rate of
complete abstinence, longer time to first drink, and greater percent days
abstinent than those taking placebo.(1) The mechanism of action of Campral in
maintenance of alcohol abstinence is not completely understood. It is believed
to restore the normal chemical balance in the brain, which is disrupted by
chronic heavy drinking.(2)
In the clinical trial program, side effects for Campral were generally
mild with the most frequently reported side effect being diarrhea.(2)
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).(2)
The recommended dose of Campral is two 333 mg tablets taken three times
daily (1998 mg total daily dose). 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.(2)
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 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(R) (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; and COMBUNOX(TM) (Oxycodone HCl and Ibuprofen) an opioid
and NSAID combination indicated for the short-term management of acute,
moderate to severe pain.
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, 2005.
*Benicar is a registered trademark of Sankyo Pharma, Inc., and Campral is
a registered trademark under license from Merck Sante s.a.s., subsidiary of
Merck KGaA, Darmstadt, Germany.
(1) Rosenthal, Richard N. "Acamprosate is Safe and Well-Tolerated in the
Long-Term Treatment of Alcohol Dependence." Abstract submitted to
American Society of Addiction Medicine, 2005 Medical-Scientific
Conference, October 1, 2004.
(2) CAMPRAL(R) Delayed-Release Tablets Prescribing Information, Forest
Laboratories, Inc., St. Louis, MO, 2004, p. 4.
SOURCE Forest Laboratories
Charles E. Triano, Vice President, Investor Relations of Forest Laboratories,
+1-212-224-6714, charles.triano@frx.com, or for Medical Professionals, 1-800-678-1605