Part B: Amendments to the Poisons Standard not referred to an expert advisory committee
5. Delegate-only decisions on medicines for human therapeutic use: New Chemical Entities (NCEs)
3.1 Safinamide
On this page: Delegate's final decision | Scheduling proposal | Background information for safinamide
Delegate's final decision
The delegate's final decision under regulation 42ZCZU of the Therapeutic Goods Regulations 1990 (the Regulations) is to amend the Poisons Standard by creating new Schedule 4, Appendix K and Appendix L entries for safinamide as follows:
Schedule 4 - New Entry
SAFINAMIDE.
Appendix K - New Entry
SAFINAMIDE
Appendix L - New Entry
SAFINAMIDE
Warning statement/s: 62 (Do not use if pregnant), 76 (Do not become pregnant during use or within (Insert number of months as per approved Product Information) month(s) of stopping treatment), 77 (WARNING - May cause birth defects).
Implementation date: 1 October 2018
Reasons:
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered by the delegate for the decision include:
- the risks and benefits of the use of a substance:
- Safinamide is a highly selective and reversible inhibitor of monoamine oxidase B to be potentially approved for idiopathic Parkinson's disease. In these uses the benefits are considered to outweigh risks at a population level.
- the purposes for which a substance is to be used and the extent of use of a substance:
- Adult patients with idiopathic Parkinson's disease (PD). Accordingly, the extent of use of the product is relatively limited to PD patients only
- the toxicity of a substance:
- Safinamide has its own distinct toxicities but these have been addressed within the benefit/risk consideration noted above.
- the dosage, formulation, labelling, packaging and presentation of a substance:
- The dose regimen, formulation, labelling, packaging and presentation of Safinamide have been considered and none of these aspects precludes scheduling of Safinamide as Schedule 4.
Scheduling proposal
The delegate of the Secretary proposed to amend the Poisons Standard with respect to safinamide, a new chemical entity (NCE) for human therapeutic use.
Background information for safinamide
Scheduling status
Safinamide is not specifically scheduled and is not captured by any entry in the Poisons Standard.
Delegate's consideration
The delegate considered the following in regards to this scheduling:
- Advice on the place in therapy of this NCE;
- The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
- Section 52E(1) of the Therapeutic Goods Act 1989 in particular: (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used 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.