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Delegate-only final decisions and reasons: NCEs, September 2019

Scheduling of chemicals and poisons

25 September 2019

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1.6 Linaclotide

Final decisions on matters not referred to an expert advisory committee

1. New Chemical Entities - medicines for human therapeutic use

1.6 Linaclotide
Delegate's final decision

The delegate's final decision under regulation 42ZCZU of the Therapeutic Goods Regulations 1990 is to include linaclotide in the Poisons Standard as follows:

Schedule 4 - New Entry

LINACLOTIDE.

Index - New Entry

LINACLOTIDE

Schedule 4

Implementation date

1 October 2019

Reasons

The matters under subsection 52E(1) of the Therapeutic Goods Act 1989 considered relevant by the delegate for the decision include:

  1. the risks and benefits of the use of a substance:
    • It is a new chemical entity with no clinical or marketing experience in Australia.
    • The benefits outweigh the risks.
  2. the purposes for which a substance is to be used and the extent of use of a substance:
    • For the management of chronic idiopathic constipation [CIC] and irritable bowel syndrome with constipation[IBS-C].
  3. the toxicity of a substance:
    • Minimal.
  4. the dosage, formulation, labelling, packaging and presentation of a substance:
    • Irritable Bowel Syndrome with Constipation.
      • The recommended dosage of linaclotide is 290 mcg orally once daily.
    • Chronic Idiopathic Constipation
      • The recommended dosage of linaclotide is 145 mcg orally once daily. A dosage of 72 mcg once daily may be used based on individual presentation or tolerability.
    • Strength/Dose Form
      • 72 μg, 145 μg and 290 μg as hard capsules for oral administration.
  5. the potential for abuse of a substance:
    • Nil.
  6. any other matters that the Secretary considers necessary to protect public health:
    • Nil.
Scheduling proposal

The delegate of the Secretary proposed to amend the Poisons Standard with respect to linaclotide, a new chemical entity (NCE) for a human therapeutic medicine.

Scheduling status

Linaclotide is not specifically scheduled and is not captured by any entry in the Poisons Standard.

Delegate's considerations
  • Subsection 52E(1) of the Therapeutic Goods Act 1989;
  • The Scheduling Policy Framework (SPF 2018);
  • The TGA evaluation report;
  • The advice of the Advisory Committee Medicines; and
  • The new drug application.

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