| Drug Name |
CAMPRAL |
| Active Ingredient(s) |
ACAMPROSATE CALCIUM |
Form(s) and
Strength(s) Available |
TABLET, DELAYED RELEASE; ORAL:333MG |
Product Information / Press Release NEW YORK, July 29 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE:FRX) and Merck KGaA (Merck) of Darmstadt, Germany, announced today that the United States Food and Drug Administration (FDA) has approved Campral(R) (acamprosate calcium) Delayed-Release Tablets 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.
Forest expects Campral to be available to physicians, patients and pharmacies around the end of the year. Developed by Merck, Campral is the first new medication in nine years to be approved in the U.S. for the treatment of alcohol dependence, a chronic disease that accounts for approximately 100,000 deaths per year.(1) Nearly 14 million Americans have a problem associated with alcohol.
"The approval of Campral offers a new therapeutic option for alcohol-dependent patients in the United States, which we hope will enable more patients to successfully control this complex and chronic disease," said Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories, Inc.
Campral was licensed to Forest in 2001. Under terms of the licensing agreement, Forest is responsible for sales and marketing activities of the product in the U.S.; Merck will manufacture and supply the product. Forest will promote Campral to key healthcare providers, focusing on treatment centers, addiction specialists and physicians most experienced with the medical management of alcoholism.
About Campral
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. Campral interacts with neurotransmitter systems and is hypothesized to restore the normal balance. This mechanism of action is different from that ascribed to currently available medications, which either block the "high" associated with alcohol or induce vomiting if alcohol is ingested.
| Mentioned |
Last |
Change |
| FRX |
50.29 |
 0.63dollars or (1.26%) |
FDA approval of Campral is based primarily on the Agency's review of safety and efficacy data from four double-blind, placebo-controlled trials. In three of these trials, Campral increased abstinence rates when used as part of a multidisciplinary approach that included various types of psychosocial support. In a fourth study, the Campral-treated group failed to show a difference on the primary efficacy endpoint, cumulative abstinence duration. In the latter trial, patients were not required to be abstinent prior to randomization as required in the positive studies. In the clinical trial program, side effects for Campral were generally mild with the most frequently reported side effect being diarrhea.
Campral is also approved and available in 28 countries outside the United States.
About Forest Laboratories and Its Products
Forest Laboratories' growing line of products includes: Lexapro(R), an SSRI antidepressant indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder; Celexa(R), an antidepressant; Namenda(R), an N-methyl-D- aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; Tiazac(R), a once-daily diltiazem, indicated for the treatment of angina and hypertension; Benicar(R), (a) an angiotensin receptor blocker indicated for the treatment of hypertension; Benicar HCT(TM), an angiotensin receptor blocker and diuretic combination product indicated for the second-line treatment of hypertension; and Aerobid(R), an inhaled steroid indicated for the treatment of asthma.
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. Actual results may differ materially from those projected.
(a) Benicar(R) is a registered trademark of Sankyo Pharma, Inc.
About Merck KGaA
Merck is a global pharmaceutical and chemical company with sales of EUR 7.2 billion in 2003, a history that began in 1668, and a future shaped by 28,300 employees in 56 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds a 74% interest and free shareholders own the remaining 26%. The former U.S. subsidiary, Merck & Co., has been completely independent of the Merck Group since 1917. For further information, please check the company Website: http:/ www.merck.de
(1) Garbutt JC., et al. Pharmacological Treatment of Alcohol Dependence.
JAMA 1999; 281:1318-1325 SOURCE Forest Laboratories, Inc. -0- 07/29/2004 /CONTACT: Charles E. Triano, Vice President, of Investor Relations, Forest Laboratories, Inc., +1-212-224-6714,
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