Reacción a "A drug reduces cocaine and alcohol use in a small clinical trial"

Does the press release accurately reflect the study?
‘I think they have produced a good summary, which is understandable and has the right amount of space.’

Is the study of good quality? Are the conclusions backed up by solid data?
‘In my opinion, the study is very well designed and correctly carried out. The data and its treatment, together with the conclusions, are coherent.’

How does this work fit in with existing evidence?
‘There is no solid evidence for the pharmacological treatment of cocaine dependence, despite the use of a large number of drugs, belonging to various therapeutic groups, which have not been approved by any drug agency’.

Have the authors taken confounding factors into account? Are there any important limitations to be considered?
‘Yes. The article considers the difficulty of evaluating some aspects and deals with them well. On the other hand, a series of limitations of the study are pointed out, for example, the number of participants which we always want to be higher’.

What are the implications for the real world?
‘I think this study is an important step in the development of the drug which will require one or more further phase 3 studies and that, if the results in phase 3 are positive, we could have the first treatment for cocaine dependence. For the moment we can say that mavoglurant is at the stage of ‘promising drug’ for cocaine dependence.

For years, a large number of drugs have been used to treat cocaine dependence, including various antidepressants, mood stabilisers, dopamine agonists, psychostimulants, neurotransmitter precursors, opioids, as well as a long list of drugs in the experimental phase. However, none of them has been approved by the drug agencies for the treatment of patients dependent on this drug.

In this sense, a subtype of the metabotropic glutamate receptor, mGluR5, is thought to be involved in the modulation of cocaine-induced addictive behaviour. Mavoglurant is a negative allosteric modulator that acts as an antagonist of this receptor and has proven effective in animal and clinical trials in reducing cocaine administration. These data, together with the good tolerability and safety demonstrated by mavoglurant in patients with fragile X syndrome, obsessive-compulsive disorder and Parkinson's disease, stimulated the realisation of a phase 2 clinical trial, as a comparison with placebo, in patients with cocaine abuse.

The results of this study show that mavoglurant was safe and generally well tolerated and reduced cocaine use (demonstrated by lower levels of benzoylecgonine, a urinary metabolite of cocaine used as a marker), compared to the placebo group. Furthermore, the clinical evaluation (CGI) of clinical improvement at the end of the study was much higher for the mavoglurant group (90.9%) than with the placebo (46.6%). If these data are confirmed in subsequent studies involving a larger number of patients, there would be sufficient arguments for possible approval by the drug agencies of the first drug to treat cocaine addiction'.