Year(s) and type of review / ECDD meetings
Drug Class

Recommendation (from TRS)

Substance identification
AM-2201 is chemically [1-(5-fluoropentyl)-1H-indol-3-yl]-naphthalen-1-yl- methanone.

Previous review
AM-2201 had not been previously pre-reviewed or critically reviewed. A direct critical review was proposed based on information brought to WHO’s attention that AM-2201 is clandestinely manufactured, poses an especially serious risk to public health and society, and has no recognized therapeutic use by any party. Preliminary data collected from the literature and from different countries indicated that this substance may cause substantial harm and that it has no medical use.

Similarity to known substances and effects on the central nervous system
AM-2201 (the 5-fluoropentyl analogue of JWH-018) is a full cannabinoid agonist with low nanomolar binding affinity at the CB1 receptor. Its interaction with these receptor subtypes correlates with a psychopharmacological profile that is shared with delta-9-THC. It appears to display a greater potency in vitro than JWH-018. Analytically confirmed cases of adverse effects, including non-fatal and fatal occurrences, have been reported in addition to instances of driving under the influence of the drug. Restlessness, hallucinations and somnolence have been noted.

Dependence potential
There is some evidence to suggest that synthetic cannabinoid receptor agonists may be able to produce tolerance and withdrawal symptoms when substance use is abruptly discontinued following regular use of high doses. Further detailed studies on these properties of AM 2201 are warranted.

Actual abuse and/or evidence of likelihood of abuse
Survey data indicate that AM-2201, like a range of other synthetic cannabinoids, shows THC-like effects in humans. In a WHO survey, 22 Member States confirmed that there was recreational/harmful use of AM-2201.

Therapeutic usefulness
AM-2201 has no recorded therapeutic applications or medical use.

The Committee noted the challenges associated with the evidence base concerning the substance. It also noted analytically confirmed cases of non-fatal and fatal intoxications involving AM-2201. The Committee therefore considered that the degree of risk to public health associated with the abuse liability of AM- 2201 is substantial. Therapeutic usefulness has not been recorded. As per the Guidance on the WHO review of psychoactive substances for international control (4), higher regard was accorded to the substantial public health risk than to the lack of therapeutic usefulness.1 The Committee recommended that AM-2201 be placed under international control in Schedule II of the 1971 Convention.

ECDD Recommendation

Inclusion in Schedule II of the 1971 Convention on Psychotropic Substances