Lefty, I got this from the Forrest Laboratory press archive about their product, the effects, etc. I hope it helps you and others.
Cynthia
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 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)
Cynthia
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 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)
Comment