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Scheduling delegate's final decisions, July 2016
Scheduling medicines and poisons
Part B – Final decisions on matters not referred to an expert advisory committee
5. New Chemical Entities - medicines for human therapeutic use
The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of eluxadoline, a new chemical entity for a human therapeutic medicine.
Eluxadoline is a locally acting, mixed mu opioid receptor (μOR) agonist and delta opioid receptor (δOR) antagonist. Eluxadoline is also an agonist at the kappa opioid receptor (κOR). The binding affinities (Ki) of eluxadoline for human μOR and δOR are 1.8 nM and 430 nM, respectively. The Ki of eluxadoline for human κOR has not been determined; however, the Ki for guinea pig cerebellum κOR is 55 nM. In animals, eluxadoline interacts with opioid receptors in the gut. Eluxadoline has demonstrated efficacy in normalising GI transit and defecation in several models of stress induced or post GI inflammation-altered GI function in animals. Eluxadoline has very low oral bioavailability and exerts no detectable central nervous system (CNS)-mediated effects when administered orally to animals at effective doses. Eluxadoline also reverses hyperalgesic responses in an animal model of acute colitis-induced visceral pain.
Eluxadoline is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).
The delegate decided to make a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.
Eluxadoline is not specifically scheduled and is not captured by any entry in the current Standard for the Uniform Scheduling of Medicines and Poisons.
Eluxadoline is not classified in New Zealand.
The delegate considered the following in regards to this application for scheduling:
- Subsection 52E(1) of the Therapeutic Goods Act 1989;
- The Scheduling Policy Framework scheduling factors;
- The new drug application; and
The delegate noted that currently there are no issues of concern that require additional control other than by inclusion in Schedule 4.
Delegate's final decision
The delegate has made a final decision to amend the Poisons Standard to include eluxadoline in Schedule 4, with an implementation date of 1 February 2017.
The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are (a) the risks and benefits of the use of a substance; (b) the purpose and the extent of use of a substance; (c) the toxicity of a substance; e) the potential for abuse.
The delegate decided that the reasons for the final decision comprise the following:
- Eluxadoline is a new chemical entity with no clinical/marketing experience in Australia;
- Eluxadoline is intended for the treatment of a condition which requires medical assessment and monitoring;
- Eluxadoline has potential for misuse and abuse; and
- Eluxadoline is an opioid agonist with very low levels of absorption from the gut. It is presented as an oral dose form and is intended to act locally within the gut. If injected eluxadoline has opioid effects on the CNS and therefore has abuse potential.
The delegate has decided that the wording for the schedule entry will be as follows:
Schedule 4 - New Entry