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Scheduling delegates' final decisions: NCEs, May 2018
Scheduling medicines and poisons
New Chemical Entities - medicines for human therapeutic use
Delegate's final decision
The delegate's final decision is to amend the Poisons Standard to include lifitegrast in Schedule 4 as follows:
Schedule 4 - New Entry
Implementation date: 1 June 2018
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate include:
- the risks and benefits of the use of a substance
- Lifitegrast is a new chemical entity with no previous clinical or marketing experience in Australia. There is clinical and marketing experience with Lifitegrast internationally.
- The medicine acts as an anti-inflammatory. It targets the interaction between lymphocyte function associated antigen and its cognate ligand intercellular adhesion molecule 1.
- the purposes for which a substance is to be used and the extent of use of a substance
- Lifitegrast will be used in 5% solution for the topical treatment of dry eye disease.
- the toxicity of a substance
- Low toxicity. There is sometimes mild eye irritation when the drops are installed. These effects are transient. As it is a topical medicine, reproductive effects are unlikely.
- the dosage, formulation, labelling, packaging and presentation of a substance
- 5% solution. The formulation for therapeutic use also contains sodium chloride, sodium phosphate dibasic anhydrous, sodium thiosulfate pentahydrate, sodium hydroxide and hydrochloric acid.
- The dose is one drop twice daily.
- The usual labelling for eye drops is appropriate.
- The medicine will be presented in 0.2ml single use containers, packaged in foil pouches (5 per pouch) in a box containing 60. This will be sufficient for a patient to use the medicine for 30 days.
The delegate of the Secretary proposed to amend the Poisons Standard with respect to lifitegrast.
Lifitegrast is not specifically scheduled and is not captured by any entry in the Poisons Standard.
The delegate considered the following in regards to this scheduling:
- 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.