3.6 Cumyl-pegaclone

3 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #31, June 2020)

3.6 Interim decision in relation to cumyl-pegaclone

Interim decision

Pursuant to regulation 42ZCZN of the Regulations, a Delegate of the Secretary has, in relation to the proposed amendment, made an interim decision to amend the current Poisons Standard in relation to cumyl-pegaclone as follows:

Materials considered

In making this interim decision, the Delegate considered the following material:

• The proposal to amend the current Poisons Standard with respect to cumyl-pegaclone;
• The three public submissions received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;
• The advice received from the Meeting of the Advisory Committee on Medicines Scheduling (ACMS #31);
• Subsection 52E(1) of the Therapeutic Goods Act 1989, in particular (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; (e) the potential for abuse of a substance; and (f) any other matters considered necessary to protect public health;
• The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
• The Scheduling handbook: Guidance for amending the Poisons Standard.

Summary of ACMS advice to the Delegate

The Committee recommended that that cumyl-pegaclone be entered in Schedule 9 of the Poisons Standard as follows:

The Committee also recommended an implementation date of 1 February 2021.

Members agreed that the relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 included: (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; (e) the potential for abuse of a substance; and (f) any other matters considered necessary to protect public health.

The reasons for the advice included:

a - the risks and benefits of the use of a substance:

• Risks
  • Cumyl-pegaclone has no therapeutic benefits established through clinical trials or research.
• Benefits
  • Use of cumyl pegaclone is associated with serious medical and psychiatric effects, including hallucinations, delusions, irritability, paranoia as well as elevated blood pressure, chest pain, vomiting.

b - the purposes for which a substance is to be used and the extent of use of a substance:

• No current human therapeutic use, or uses in industrial, agricultural, or cosmetic products.
• Current use is in the context of non-medical substance use.

c - the toxicity of a substance:

• Described by clinicians as consistent with "serotonin toxicity".
• Cumyl-pegaclone is a potent full agonist of the cannabinoid CB1 and CB2 receptors. Cannabinoid receptor binding affinity and efficacy for the cannabinoid receptors CB1 and CB2 suggest that the formation of a γ‐carboline core leads to a more potent compound when compared to the corresponding indole core structures.

d - the dosage, formulation, labelling, packaging and presentation of a substance:

• No approved product currently marketed.

e - the potential for abuse of a substance:

• Established potential for abuse. It has been synthesised for its psychoactive properties and recreational drug use. Tolerance to effects and withdrawal symptoms have been reported.

f - any other matters considered necessary to protect public health:

• Whilst cumyl-pegaclone is captured by the group entry for synthetic cannabinomimetics, specific listing will remove any ambiguity surrounding the scheduling of this substance.
• Evidence of harms in Australia have been documented.

Reasons for the interim decision (including findings on material questions of fact)

I have made an interim decision to amend the current Poisons Standard and create a new Schedule 9 entry for cumyl-pegaclone. The reasons for my decision are set out below.

Cumyl pegaclone is a synthetic cannabinoid (SC) and new psychoactive substance (NPS) that is currently captured by the Schedule 9 entry for synthetic cannabinomimetics. Cumyl-pegaclone has a gamma-carboline core structure that is different from other synthetic cannabinomimetics, and for this reason, I have made a decision to create a specific Schedule 9 entry to provide clarity that the substance is prohibited. It is my view that this decision will also remove ambiguity in any prosecutions for possession and sale of the substance.

I have determined that cumyl-pegaclone meets the Schedule 9 Scheduling Factors in the Scheduling Policy Framework (SPF) 2018. I took into account that cumyl-pegaclone has no established medical, industrial, agricultural or cosmetic uses and as a synthetic cannabinoid it can cause psychoagitation, cardiovascular effects, sedation and intoxication. I am satisfied that a high level of control is required through prohibition of manufacture, possession, sale or use to prevent abuse, misuse or diversion into illicit activities.

I agree with the Committee's finding that the relevant provisions of section 52E of the Therapeutic Goods Act 1989 are (a) the risks and benefits of the use of a substance; (b) the purpose for which a substance is to be used and the and extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; (e) the potential for abuse of a substance; and (f) any other matters that the Secretary considers necessary to protect public health.

Proposed implementation date

1 February 2021