Efficacy: The Campral® (acamprosate calcium) Delayed-Release Tablets NDA included efficacy data from three randomized, placebo-controlled European trials of 998 alcohol-dependent patients. Campral significantly increased abstinence rates when used as part of a multidisciplinary approach that included various types of psychosocial support versus placebo. Abstinence rates were up to 3 times higher in Campral-treated patients than in placebo-treated patients. 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.

Adverse Effects: In the clinical trial program, side effects for Campral were temporary with the most frequently reported side effect being diarrhea (16% in pooled data vs. 10% for placebo).

In placebo-controlled trials of 6 months or less, 8% of Campral treated patients discontinued due to an adverse event, compared with 6% of patients treated with placebo. In studies longer than 6 months, the discontinuation rate due to adverse events was 7% in both placebo-treated and Campral-treated patients.

Campral has been shown to have no addiction potential.

Safety: Campral, used by over 1.5 million patients worldwide, has proven to be safe and well tolerated.

Campral has a low potential for drug-drug interactions and can be taken with medications commonly prescribed in this patient population, including anxiolytics, hypnotics and sedatives (including benzodiazepines), nonopiod analgesics and anti-depressants.

Campral® is contraindicated in patients with severe renal impairment (creatinine clearance =30 mL/min) and requires a dose reduction in patients with moderate renal impairment (creatinine clearance of 30-50 mL/min).

In placebo-controlled trials, events related to suicide (i.e., suicidal ideation, suicide attempts, suicide events) occurred infrequently in either group, but were more common with Campral. Rates of completed suicides, however, were similar between Campral-treated and placebo-treated patients.

Dosing: The recommended daily dose is two 333 mg tablets taken three times per day.

Treatment with Campral should be initiated as soon as possible following alcohol withdrawal and should be maintained if the patient relapses. Medication should be used as part of a comprehensive management program that includes psychosocial support.

Clinical Trials: FDA approval of Campral is based primarily on the Agency's review of safety and efficacy data from three double-blind, placebo-controlled trials. In these trials, Campral increased abstinence rates when used as part of a multidisciplinary approach that included various types of psychosocial support.

Additional parameters evaluated in the pivotal trials that demonstrated a statistically significant benefit in favor of Campral over placebo included time to first drink and percent days abstinent.

1. In a 13-week study, 38% of Campral-treated patients maintained complete abstinence versus 13% for placebo-treated patients.
2. In a 48-week trial, 28% of patients taking Campral maintained complete abstinence versus 13% of those taking placebo.
3. In a third, 52-week study, 16% of Campral-treated patients remained abstinent throughout the year, versus 9% on placebo.