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Home » Drug Information » FDA Approved Drugs » 2004
Medical Areas: Pharmacology/Toxicology | Family Medicine

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Campral (acamprosate calcium)

The following drug 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

General Information

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.

Clinical Results

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.

Side Effects

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.

Mechanism of Action

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.

Literature References

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.

Additional Information

For additional information regarding Campral or alcohol dependencer, please contact the Campral Web Site