Our Review Summary
This story discusses nalmefene, an opioid antagonist, which is a drug that affects the brain’s dopamine system and is thought to reduce the pleasurable sensation associated with addictive behaviors such as compulsive gambling. The drug was FDA approved for the treatment of alcoholism in 1994, but it is still under study for the treatment of other addictions. Nalmefene was tested in a multi-site, randomized, double-blind trial; however, there were only 207 participants, and of these, only 73 actually completed the full 16-week trial. There was no mention of this in the news story, and only brief discussion that a third of the participants dropped out due to nausea and “other side effects”. Other side effects included insomnia and dizziness and were slightly greater in those given a higher dose of nalmefene. Though the study was well-designed, results would not likely be generalizable to a larger population based solely on this small group of compulsive gamblers treated with nalmefene. No quantitative data is provided on the efficacy of the drug, and no information is provided on potential long-term side effects, namely the long-term side effects of this class of drug on the liver. Other opioid antagonist drugs such as naltrexone have shown some toxicity to the liver. Nalmefene does not appear to have the same incidence of toxicity, but long-term safety has not been studied. If this is a pill taken daily, as might be expected in patients with a chronic condition, more long-term data on liver and other toxicities is needed. No information is provided on the cost of the drug. Lastly, the journalist cites the primary author of the study, noting he has “no financial stake in BioTie”, maker of nalmefene, however, two other researchers are employees of BioTie Therapies, and in the disclosure section of the journal article there is a note that the study was supported by BioTie Therapies Corp.
Criteria
Not Satisfactory
No mention of
the cost of treatment.
Not Satisfactory
This study was only 16 weeks and since compulsive
gambling, like other addictions, is a chronic disease, long-term data would be needed to prove efficacy and safely of this
medication. The story provided no absolute quantitative data on safety of efficacy or relative risk reduction in those who
took nalmefene. What’s the number needed to treat (NNT) in order to see a benefit? Additionally, results were slightly
better in higher dose of the drug, but these people experienced more intolerable side effects and were less likely to remain
in the study.
Satisfactory
Mentions side effects such as nausea so bad that 1/3 of participants dropped out of the study. Insomnia and
dizziness were also common in the groups which took nalmefene. Not discussed was the potential long-term side effects of
this class of drug, namely the effect on the liver. The trial was only 16 weeks. Other opioid antagonist drugs such as
naltrexone have shown abnormalities in liver tests. Nalmefene does not appear to have the same incidence of toxicity, but
long-term safety has not been studied. If this is a pill taken daily, more long term data on liver toxicity is needed.
Not Satisfactory
Does not mention that this was a multi-site, double-blind,
randomized controlled study. Study included 207 people initially, but only 24 people in the placebo group and 49 in the
nalmefene group completed the 16-week trial. Though the study was well-designed, results would not likely be generalizable to
a larger population based on this small group of compulsive gamblers.
Satisfactory
Story includes a caveat that this is
“not a magic pill”. Gives U.S. incidence of compulsive gambling.
Not Satisfactory
Cites primary author of the study, noting he has “no financial stake in BioTie”, maker of nalmefene. However, 2
other authors are employees of BioTie and in the disclosure section of the journal article there is a note the study was
supported by BioTie. The story didn’t mention this.
Not Satisfactory
Mentions other biomedical research for
addictions such as gambling and the need for combined pharmacology and behavioral interventions, such as therapy. No real
comparison with other agents/studies in terms of treatment efficacy or safety profile.
Not Satisfactory
Not mentioned. Approved by FDA in 27 for treatment of alcoholism. Investigational drug not
currently approved for treatment of other addictions, such as gambling.
Satisfactory
Mentions novelty of
treatment for gambling addiction. Not novel for other addictions. The ability of opiate antagonists to block compulsive
behaviors has been well described previously. See (Opioid antagonists in the treatment of impulse-control disorders.
J Clin
Psychiatry. 191 Apr;59(4):159-64. )
Total Score: 3 of 9 Satisfactory
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