NALMEFENE DOES WELL IN PHASE III CLINICAL STUDIES FOR THE TREATMENT OF ALCOHOL DEPENDANCE

NALMEFENE DOES WELL IN PHASE III CLINICAL STUDIES FOR THE TREATMENT OF ALCOHOL DEPENDANCE

The last study in its Phase 3 program evaluating nalmefene for the treatment of alcohol dependence has shown the encouraging results. Results from this 718 patient, double-blind, placebo controlled trial were consistent with the profile observed in previous clinical studies of nalmefene.Nalmefene is the first treatment that has been specifically developed to help patients reduce their harmful levels of alcohol consumption, therefore offering patients, physicians and payors a highly differentiated treatment option. Nalmefene builds on a novel principle of treating alcohol dependence. Unlike existing therapies, treatment with nalmefene is not aimed at keeping patients from drinking. Instead, nalmefene helps patients control and limit the intake of alcohol. This is supported by specialists as a valuable treatment option to increase willingness among patients to initiate treatment and to promote compliance. In addition, nalmefene distinguishes itself by being available as a tablet formulation to be taken only according to need, whereas existing pharmaceuticals must be taken continuously over a longer period of time and are aimed at maintaining abstinence.

Lundbeck assessed a wide range of primary and secondary endpoints in its Phase 3 program for nalmefene including: number of heavy drinking days per month, total alcohol consumption, proportion of responders based on drinking measures, alcohol dependence symptoms and clinical status, liver function and other laboratory tests, pharmaco-economic outcomes and treatment discontinuation effects. All assessments were consistently in favour of nalmefene compared to placebo, though some were not statistically significant at every single time point. 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.Nalmefene is a small molecule opioid receptor antagonist that inhibits the reward pathway in the brain that reinforces the desire and craving for alcohol and other addictive substances. As a result, nalmefene removes a person’s desire to drink.Alcohol dependence is a disease in which the afflicted person continually craves alcohol, is unable to limit his or her drinking, needs to drink greater amounts to get the same effect and has withdrawal symptoms after stopping alcohol use. Alcohol dependence also has potentially fatal consequences such as liver cirrhosis and cancer, among others. As a result, this disease is one of the most serious health concerns in the western world, both socially and economically, with estimated associated costs to society of at least EUR 200 billion per annum. 10% of deaths and 25% of all emergency room admissions in the western world are directly alcohol related. According to the World Health Organization, there are 60 million people inEuropealone who are ‘riskful’ consumers of alcohol, which is categorized as alcohol consumption of 40-60 grams (5-6 standard drinks) by females and 60-100 grams (7-8 standard drinks) by males on a single drinking day. Despite this, alcohol dependence tends to be severely under-diagnosed with only approximately 13% of alcohol dependants receiving treatment, characterizing it as a large unmet medical need.

Currently, conventional methods of treating alcohol dependence require abstinence from drinking as a starting point – a high hurdle for an alcohol dependent patient. There are only a few pharmaceutical compounds that have received marketing approval to help alcohol dependent patients maintain abstinence. All these treatments, including psychosocial counseling measures, cannot prevent patients from relapsing and the long term prognosis remains poor. There are no approved therapies on the market yet to proactively help curb a person’s urge to drink

REFERENCE

1. www.globalpharmasectornews.com

 2. www.nature.com

 3. www.the-alcoholism-guide.org

ASLAM ARGODN

FIRST YEAR M PHARM

AL-SHIFA COLLEGE OF PHARMACY