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Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices To be added to Schedule II of the Convention on Psychotropic Substances 1971:
CUMYL-PEGACLONE
chemical name: 5-pentyl-2-2-phenylpropan2-yl-2,5-dihydro-1H-pyrido4,3-bindol-1one MDMB-4en-PINACA
chemical name: methyl 3,3-dimethyl-2-1pent-4-en-1-yl-1H-indazole-3carboxamidobutanoate 3-methoxyphencyclidine chemical name: 1-1-3methoxyphenylcyclohexylpiperidine Diphenidine chemical name: 1-1,2diphenylethylpiperidine To be added to Schedule IV of the Convention on Psychotropic Substances 1971:
Clonazolam chemical name: 6-2-chlorophenyl-1-methyl8-nitro-4H-benzof1,2,4triazolo4,3a1,4diazepine Diclazepam chemical name: 7-chloro-5-2-chlorophenyl1-methyl-1,3-dihydro-2Hbenzoe1,4diazepin2-one Flubromazolam chemical name: 8-bromo-6-2-fluorophenyl1-methyl-4H-benzof1,2,4triazolo4,3a1,4diazepine The assessments and findings on which these recommendations are based are set out in detail in the forty-third meeting report of the WHO Expert Committee on Drug Dependence. An extract of this report, providing a summary of the assessment and recommendations made by the ECDD, is contained in Annex 1 to this letter.
I am very pleased with the ongoing collaboration between WHO, the United Nations Office on Drugs and Crime UNODC
and the International Narcotics Control Board INCB and in particular, how this collaboration has benefited the work of the WHO Expert Committee on Drug Dependence and more generally, the implementation of the operational recommendations of the United Nations General Assembly Special Session 2016.

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Annex II
Summary Assessment and Recommendations of the 43rd Expert Committee on Drug Dependence, 1216 October 2020
To be added to Schedule I of the Single Convention on Narcotic Drugs 1961:
Isotonitazene Substance identification Isotonitazene Chemical name: N,Ndiethyl-2-2-4-isopropoxybenzyl-5-nitro-1Hbenzodimidazol-1-ylethan-1-amine belongs to the 2-benzylbenzimidazole group of compounds, which includes the closely related opioids etonitazene, metonitazene, and clonitazene. It is found in yellow, brown, or off-white powder forms.
WHO Review History Isotonitazene has never been formally reviewed by WHO and is not currently under international control. Information was brought to WHOs attention that this substance is clandestinely manufactured,
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poses a risk to public health, and has no recognized therapeutic use.
Similarity to Known Substances and Effects on Central Nervous System Isotonitazene is a chemical analogue of etonitazene and clonitazene, both of which are Schedule I compounds under the Single Convention on Narcotic Drugs, 1961.
Isotonitazene is a potent opioid analgesic with a rapid onset of action. Preclinical studies have demonstrated that isotonitazene is more potent than fentanyl and hydromorphone, and substantially more potent than morphine. There is limited research on the effects of this compound on the central nervous system, but given its demonstrated potency at the m-opioid receptor, it would be expected to produce analgesia, respiratory depression and sedation.
Dependence Potential No controlled animal or human studies have assessed the dependence potential of isotonitazene. As a potent m-opioid agonist, it would be expected to produce dependence.
An unverified online report described dependent use and withdrawal symptoms, including flu-like symptoms and anxiety.
Actual Abuse and/or Evidence of Likelihood of Abuse There are no controlled studies of the abuse potential of isotonitazene, but as a potent m-opioid receptor agonist, it would be expected to produce euphoria and other effects predictive of high abuse liability.
Due to its relatively recent appearance on the illicit drug market, there is limited information on the prevalence of use of isotonitazene or its associated harms.
Seizures have been reported in multiple countries and regions. It is noted to be used via a range of routes including sublingually, vaping and intravenously.
The number of deaths involving isotonitazene has increased in a short time span. Deaths commonly occur in combination with other opioids or benzodiazepines. Isotonitazene deaths share common features with heroin deaths, including evidence of injection, and signs consistent with opioid overdose such as pulmonary and/or cerebral oedema. Deaths are likely to be underreported due to its recent and rapid appearance.
Recommendation Isotonitazene Chemical name: N,Ndiethyl-2-2-4-isopropoxybenzyl-5-nitro-1Hbenzodimidazol-1-ylethan-1-amine has a mechanism of action such that it is liable to similar abuse and productive of similar ill effects as other opioids which are controlled under Schedule I of the 1961 Single Convention on Narcotic Drugs. Its use has been reported in a number of countries and has been associated with adverse effects including deaths. It has no known therapeutic use and is likely to cause substantial harm.
Therapeutic Usefulness Isotonitazene is not known to have any therapeutic use.

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To be added to Schedule II of the Convention on Psychotropic Substances 1971:
CUMYL-PEGACLONE
Substance Identification CUMYL-PEGACLONE Chemical name: 5pentyl-2-2-phenylpropan-2-yl-2,5-dihydro1H-pyrido4,3-bindol-1-one is a synthetic cannabinoid. It has been found in seized material formulated for smoking and vaping.
WHO Review History CUMYL-PEGACLONE has never been formally reviewed by WHO and is not currently under international control.
Information was brought to WHOs attention that this substance is clandestinely manufactured, poses a risk to public health, and has no recognized therapeutic use.
Similarity to Known Substances and Effects on Central Nervous System CUMYL-PEGACLONE is a synthetic cannabinoid with a mechanism of action similar to that of other synthetic cannabinoids. It is a potent full agonist at CB1 receptors.
There are no controlled studies of its effects, but there are online user reports describing euphoria, dissociation, red eyes, dry mouth and appetite stimulation. These effects are consistent with known cannabinoid agonist effects.
Dependence Potential There are no controlled animal or human studies that address the dependence potential of CUMYL-PEGACLONE. However, CUMYL-PEGACLONE has been shown to be a full and potent agonist at the CB1 receptor and therefore would be expected to produce dependence consistent with other CB1
receptor agonists.
Actual Abuse and/or Evidence of Likelihood of Abuse There are no controlled animal or human studies that address the abuse potential of CUMYL-PEGACLONE.
A number of countries across several regions have reported that CUMYLPEGACLONE is being used for its psychoactive properties.
There are reports of adverse effects such as seizures and of fatalities involving CUMYLPEGACLONE. While other drugs were present, CUMYL-PEGACLONE was deemed to be a causal or contributory factor in a number of these deaths.
Therapeutic Usefulness CUMYL-PEGACLONE is not known to have any therapeutic use.
Recommendation CUMYL-PEGACLONE Chemical name: 5pentyl-2-2-phenylpropan-2-yl-2,5-dihydro1H-pyrido4,3-bindol-1-one is a synthetic cannabinoid receptor agonist with a mode of action that suggests a likelihood of dependence and abuse, and similar ill-effects to other synthetic cannabinoids. Its use has been associated with severe adverse effects and fatalities. The effects of CUMYL-PEGACLONE are similar to those of other synthetic cannabinoids that are controlled under Schedule II of the
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