Clinical Trials Resource Center

Alcohol Dependence

March 12, 2012

H Lundbeck released results from three phase III trials of nalmefene for the treatment of alcohol dependence. The trials enrolled 1,997 subjects. The first two placebo-controlled studies (ESENSE1 and ESENSE2) assessed the efficacy of 20 mg doses of nalmefene on excessive alcohol consumption and on the overall alcohol intake per month evaluated over six months. In the third study (SENSE), subjects were treated for 12 months to confirm the drug was well tolerated. The primary goal of ESENSE 1 and ESENSE 2 was to evaluate the efficacy of as-needed use of Selincro versus placebo in reducing the number of heavy drinking days (HDD) and the monthly total alcohol consumption (TAC) over a period of six months. The primary objective of SENSE was to evaluate the long-term safety and tolerability of Selincro over a period of 52 weeks, as well as the efficacy versus placebo at six months. In ESENSE 1 and ESENSE 2, Selincro was superior to placebo in reducing the number of HDDs (p<0.05 in both studies) and TAC (ESENSE 1, p<0.05; ESENSE 2, p≡0.088) at month six. In SENSE, Selincro was more efficacious than placebo (p<0.05) in reducing the number of HDDs and TAC at the majority of the time points and at the end of the study, although not at month six. Selincro was generally well tolerated over 52 weeks. The most frequent adverse events included dizziness, insomnia and nausea.

June 20, 2011

Biotie and H. Lundbeck reported initial results from three phase III trials of nalmefene for the treatment of alcohol dependence. The trials enrolled approximately 2,000 subjects. The first two studies (ESENSE1 and ESENSE2) assessed the efficacy of 20 mg doses of nalmefene on excessive alcohol consumption and on the overall alcohol intake per month in a treatment cycle of 24 weeks. In the third study, SENSE, the subjects were treated for 12 months to confirm drug safety and tolerability. In ESENSE1 and -2 all assessments were consistently in favor of nalmefene compared to placebo. Overall, nalmefene reduced heavy drinking days and total alcohol consumption by more than 50% compared to pre-treatment baseline. The effect was observed already during the first month of treatment and was maintained throughout the study period in the three trials. SENSE confirmed the safety, tolerability and efficacy. The most common adverse events were dizziness, insomnia and nausea and the treatment effect of nalmefene was maintained and improved after one year of treatment.

July 9, 2007

Alkermes announced positive results from a phase I/II trial of ALKS 29 for the treatment of alcohol addiction. This randomized, double-blind, placebo-controlled trial enrolled 150 alcohol dependent subjects. The subjects were segmented into several dose groups and received daily oral administrations of ALKS 29 or placebo for eight weeks. Results revealed the subjects treated with ALKS 29 demonstrated statistically significant improvement compared to placebo in terms of percent of days abstinent, percent of heavy drinking days, and average number of drinks per day. ALKS 29 was generally well tolerated during the study. Based on the results, Alkermes plans o move forward with the development of ALKS 29.

May 30, 2005

Alkermes announced positive results of a 12-month phase III extension study of Vivitrex (naltrexone long-acting injection), for the treatment of alcohol dependence, at the Annual Meeting of the American Psychiatric Association in Atlanta. Data demonstrated that long-term administration of Vivitrex was efficacious in reducing heavy alcohol consumption. Specifically, subject continuing on active treatment from the original 6-month study experienced further reduction in mean number of heavy drinking days per month, from 2.6 days to 1.6 days after 18 months of total treatment. Subjects who received placebo in the original study and were switched to Vivitrex in the extension experienced a similar reduction, from 5.2 days to 1.8 days. This open-label extension study enrolled over 85% (n=332) of the subjects from the original study, who received once-monthly intramuscular injections of one of two doses of Vivitrex (190 mg or 380 mg) for 12 months.

April 11, 2005

Alkermes reported positive results of a phase III trial of Vivitrex (naltrexone long-acting injection), for the treatment of alcohol dependence. Data met their primary endpoint, producing a significant reduction in the incidence of heavy drinking vs. placebo (p=0.0245). Efficacy was also seen in a number of secondary endpoints in the highest dosing group, including reduction in median number of heavy drinking days per month (3, vs. 19 for placebo), and a reduction of heavy drinking (5 or more drinks per day for men, 4 or more for women) within the first month of treatment. Adverse events were generally mild and decreased over the course of treatment, with injection site reactions occurring most frequently. This multi-center, double-blind, placebo-controlled clinical trial included 624 subjects with a history of alcohol dependence, who were randomized to receive once monthly injections of Vivitrex 380 mg (n=205), Vivitrex 190 mg (n=210), or a placebo (n=209) for 6 months, in addition to low-intensity supportive counseling.

January 13, 2003

DrugAbuse Sciences reported positive results from a phase III trial investigating a sustained release formulation of Naltrexone Depot for the treatment of alcoholism. Results showed that after six months of treatment with the drug subjects were approximately four times less likely to drink heavily and approximately eight times more likely to avoid alcohol altogether than those compared to placebo and psychotherapy. Subjects from 29 treatment sites throughout the U.S. were treated with five sessions of motivational enhancement therapy over the first 12 weeks in the study.

July 15, 2002

The FDA has issued a non-approvable letter for acamprosate, a medication designed to help maintain abstinence in patients with alcohol dependence. After completing its review of the NDA, the FDA has indicated that the data did not adequately establish the safety and efficacy of the drug. The FDA has requested that at least one additional US trial be conducted, as well as additional pharmacokinetic analyses and pre-clinical studies. Lipha S.A., a subsidiary of Merck KGaA, developed acamprosate and licensed the US marketing and distribution rights to Forest Laboratories.

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