Concerns over evidence for nalmefene: where next for drugs to treat dependence?

Pills 2A freshly published study published in the journal Addiction has raised questions over the legal force of evidence that led to the approval of nalmefene similar to a drug for the treatment of spirits of wine dependence. The study says that ‘poor evidence’ raises dilemmas for clinicians and poses questions with respect to the alcohol field and the measure for approving drugs.

Indeed when nalmefene (in subordination to the brand name Selincro®) first gained alertness in 2013 following approval by the European Medicines Agency (EMA), we published a visitant post by Clinical Nurse Manager Dylan Kerr highlighting a designate by ~ of the issues addressed in the of recent origin study. For example, what is the rigorous role the drug plays in narrative to ‘psychosocial intervention’ which are unavoidable component alongside prescribing of the unsalable article. What are the implications for this in practice given difficulties in implementing even uncompounded ‘brief interventions’ in Primary Care settings? Arguably distracting from such questions, dubious media coverage and headlines followed, of the like kind as the Mirror’s ‘New £3 pill to ‘reparative’ alcoholism can stop binge boozing’.

Asides from the questions completely the validity of the evidence, nalmefene’s target group itself was already regarded for the re~on that controversial by some. Unlike most pharmacological treatments in favor of alcohol problems it was authorised to sustenance those seeking to reduce their toping rather than abstain, but not to subsist prescribed to drinkers with signs of natural dependency. As such, the drug is aimed at ‘to a reduced state to moderate severity’ dependent drinkers who would typically exist offered only psychosocial or other non-unsalable article based interventions if engaging in sustain. 

With regard to the questions athwart the evidence for the drug’s effectiveness itself, the appropriate of this open access study concluded that nalmefene was licensed and recommended contemptuous opposition ‘problems with the registration, design, dissection and reporting of clinical trials’ as being the drug. Whilst not directly questioning the truth that three of the main trials were funded ~ the agency of the producer of nalmefene – Lundbeck – the study highlights that ‘concerns continue regarding industry influence in health technology tax more widely’.

Furthermore another study, a meta-analysis of research trials also casts uncertainty over the effectiveness of the medicine, finding no impact on mortality and raising other issues of that kind as the level of side effects and withdrawal of participants from trials.

The issues and concerns raised by these two publications over the make manifest for nalmefene were also explored in a Mental Elf blog trait. The blog explores various issues identified through the trials including why they did not collate nalmefene with naltrexone, a drug by a similar mechanism of action. Indeed naltrexone is before that time used in substance misuse treatment unless as a generic drug and is considerably cheaper. The Lundbeck sponsored trials moreover used a psychosocial intervention known in the same proportion that ‘BRENDA’, but this has been questioned before this BRENDA is less intensive than the psychosocial interventions recommended ~ dint of. NICE for the treatment of highly rectified spirit dependence.

Clinicians and policymakers left to try in the balance it up?

As the Addiction essay suggests, this may leave those involved in alcohol treatment with a number of dilemmas above the possible use of nalmefene. Indeed in that place may not be a clear consent on the exact role pharmacology should disport in alcohol addiction treatment, particularly whereas seeking to reach larger populations of ‘appear stormy severity’ dependent drinkers. Generally guidance says that drugs have power to play a useful role for some individuals, particularly alongside evidence based approaches of the like kind as psychosocial therapies. However many may handle that ‘low utilisation’ of pharmacotherapy is not the strength barrier to improving treatment uptake and outcomes, individuality for those without physical dependence.

As as being the future of nalmefene itself, merely time will tell whether it becomes a to a greater degree widely used option, or if further research trials will be conducted infectious account of the issues raised. Lundbeck notwithstanding no longer appear to be prioritising nalmefene in the UK spite having sponsored and supported a stroll of alcohol initiatives over recent years such as conferences and local alcohol pecuniary means.

NICE responded to the Addiction document by stating that the decision to commend the drug had followed standard procedures and their ‘appraisal protuberance for nalmefene thoroughly interrogated the proof base’. The authors of the study admitting are unlikely to feel this suit the core issue; the paper states the ‘investigation makes clear the need to study the involvement of the pharmaceutical effort; labors in alcohol treatment trials and the resulting implications for the literature’. It adds, ‘alcohol problems are network, and require evidence unbiased by established interests’ – a position few in the addiction field would disagree with.

It is needful for those addicted to enter reinvigoration centers where they can be provided with counseling.

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