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Scheduling delegate's final decisions, January 2018

Scheduling medicines and poisons

25 January 2018

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1.20. Telotristat ethyl

Scheduling proposal

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

Substance summary

Telotristat ethyl, as telotristat etiprate, is a tryptophan hydroxylase inhibitor. Telotristat etiprate is the hippuric acid salt form of telotristat ethyl (the free base). Telotristat is the active metabolite of the prodrug, telotristat ethyl.

Both the prodrug (telotristat ethyl) and its active metabolite (telotristat) are inhibitors of L-tryptophan hydroxylases (TPH1 and TPH2, the rate limiting steps in serotonin biosynthesis). Serotonin plays a critical role in regulating several major physiological processes, including secretion, motility, inflammation, and sensation of the gastro-intestinal tract, and is over-secreted in patients with carcinoid syndrome. Through inhibition of peripheral TPH1, telotristat reduces the production of serotonin, thus alleviating symptoms associated with carcinoid syndrome.

Scheduling status

Telotristat ethyl 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

Telotristat ethyl is classified as a prescription medicine in the United States of America. It is unclassified in New Zealand and Canada.

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 telotristat ethyl 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

TELOTRISTAT ETHYL.

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.

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

  • Telotristat ethyl is an NCE with no marketing experience in Australia.

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