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Scheduling delegate's final decisions, January 2018

Scheduling medicines and poisons

25 January 2018

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1.14. Patiromer sorbitex calcium

Scheduling proposal

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

Substance summary

Patiromer sorbitex calcium is a crosslinked polymer anion of 2-propenoic acid, 2-fluoro-, polymer with diethenylbenzene and 1,7-octadiene with calcium-sorbitol counterion. Patiromer sorbitex calcium is an amorphous, free-flowing powder that is composed of individual spherical beads.

Patiromer sorbitex calcium is indicated for the treatment of hyperkalaemia in adults.

Property Patiromer sorbitex calcium
CAS number 1415477-49-4
Chemical structure
Molecular formula C613H765F114O399Ca57
Molecular weight 5.6 × 1017 g/mol[1]
Chemical names Hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes calcium
Other names Patiromer sorbitex calcium (AAN)

Scheduling status

Patiromer sorbitex calcium 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

Patiromer sorbitex calcium is not classified in New Zealand and Canada, but is listed as a prescription only medicine in the United States of America and the European Union.

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 TGA evaluation report.

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 patiromer sorbitex calcium 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

PATIROMER SORBITEX CALCIUM.

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

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

  • Patiromer sorbitex calcium is an NCE with no clinical/marketing experience in Australia.
  • The toxicity of patiromer sorbitex calcium is of low risk.
  • The potential for abuse of patiromer sorbitex calcium is minimal.

Footnotes

  1. The molecular weight of a 100 micrometre patiromer sorbitex calcium bead is calculated using an experimentally derived value for density and the theoretical calculated value for volume.

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