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Scheduling delegate's final decisions, January 2018

Scheduling medicines and poisons

25 January 2018

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1.19. Tafenoquine succinate

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of tafenoquine succinate, a new chemical entity (NCE) for a human therapeutic medicine.

Substance summary

Tafenoquine succinate is an 8‐aminoquinoline which eradicates P. vivax liver hypnozoites. The molecular target of tafenoquine is not known.

Tafenoquine succinate is indicated for radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients aged 16 years and older.

Scheduling status

Tafenoquine succinate is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) – the Poisons Standard that was in effect at the time the decision was made (Poisons Standard October 2017 (SUSMP No. 18)).

International regulations

Tafenoquine succinate is unclassified in New Zealand, Canada and the United States of America.

Delegate’s consideration

The delegate decided to make a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.

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 (2015) scheduling factors; and
  • The new drug application (pre-submission documents).

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 tafenoquine succinate in Schedule 4, with an implementation date of 1 February 2018.

The delegate has decided that the wording for the schedule entry will be as follows:

Schedule 4 – New Entry

TAFENOQUINE SUCCINATE.

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; and (d) the dosage, formulation, labelling, packaging and presentation of a substance.

The delegate decided that the reasons for the final decision comprise the following:

  • Tafenoquine succinate is an NCE with no clinical or marketing experience in Australia.
  • Requires specialised medical supervision for usage.
  • Presentation will be in compliance with the prescription medicines labelling requirements.

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