Home » Drug Information » FDA-Approved Drugs » 2004
Medical Areas: Pharmacology/Toxicology
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Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Forest Laboratories
Approval Status: Approved August, 2004
Treatment Area: Alcohol dependence
Campral (acamprosate) is a structural analogue of the amino acid
homotaurine and the inhibitory neurotransmitter gamma-aminobutyric
acid (GABA). While it's specific mechanism of action is not
entirely understood, neurotransmossion systems involving GABA and
it's excitatory counterpart glutamate are observed to be thrown
out of equilibrium when chronically exposed to alcohol; Campral, by
mimicing GABA's actions and interacting with these systems
directly, is thought to help restore this equilibrium.
It is specifically indicated for the maintenance of
abstinence from alcohol in patients with alcohol
dependence who are abstinent at treatment initiation. It has not
been established as effective for initiating abstinence in patients
who have not done so on their own prior to taking the drug, and it
was designed to be a portion of a full behavioral and
pharmacological treatment program. Campral has also not been shown
to be effective in patients with multiple subtance dependencies
including alcohol.
Campral is administered as an oral tablet, with a recommended
dosage of two tablets (each containing 333 mg of Campral) thrice
daily.
FDA approval of Campral was based on three double-blind,
placebo-controlled clinical studies enrolling a combined total of
998 subjects. The trials ranged from 90 to 360 days, with all
subjects receiving at least one dose of Campral or placebo. All
subjects had a history of alcohol abuse and dependence, and all had
undergone inpatient detoxification and were abstinent from alcohol
on the day of randomization. All subjects received their treatment
in combination with standard psychosocial couselling. In all three
studies, treatment with Campral yielded a greater portion of
subjects maintaining abstinence than with placebo.
A fourth clinical study invesigated the efficacy of Campral in
subjects with multiple substance dependencies, and in patients who
had not established abstinence prior to dosing. In these studies,
Campral was not shown to be superior to placebo.
Adverse events associated with the use of Campral may include,
but are not limited to, the following:
- Diarrhea
- Nausea
- Flatulence
- Pruritus
In addition to these events, acute kidney failure was observed
in 3 subjects during the trials. A causal role of Campral has not
been found, and it has not been determined if these events were
relevant to clinical treatment.
Campral (acamprosate) is a structural analogue of the amino acid
homotaurine, the inhibitory neurotransmitter gamma-aminobutyric
acid (GABA), and the neuromodulatory amino acid taurine. The
drug's specific mechanism of action is not entirely understood,
but it is thought to help restore GABA-glutamate equilibrium by
acting specifically on sites of alcohol dependence. It has been
shown to have little to no additional CNS activity, and did not
demonstrate significant behavioral effects (depression, anxiety,
dizziness, etc.) significantly more often than placebo.
McGregor IS, Gallate JE. Rats on the grog:
Novel pharmacotherapies for alcohol craving. Addictive
Behaviors 2004 Sep;29(7):1341-57
Kiritze-Topor P, Huas D, Rosenzweig C, Comte S, Paille
F, Lehert P. A PRAGMATIC TRIAL OF ACAMPROSATE IN THE
TREATMENT OF ALCOHOL DEPENDENCE IN PRIMARY CARE. Alcohol and
Alcoholism 2004 Aug 10
Boeijinga PH, Parot P, Soufflet L, Landron F, Danel T,
Gendre I, Muzet M, Demazieres A, Luthringer R.
Pharmacodynamic effects of acamprosate on markers of cerebral
function in alcohol-dependent subjects administered as pretreatment
and during alcohol abstinence. Neuropsychobiology
2004;50(1):71-7.
For additional information regarding Campral or alcohol
dependencer, please contact the Campral Web Site