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Scheduling delegate's final decisions, June 2017
Scheduling medicines and poisons
Part B - Final decisions on matters not referred to an expert advisory committee
New Chemical Entities – medicines for human therapeutic use
The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of fosfomycin, a new chemical entity (NCE) for a human therapeutic medicine.
The proposed indications for Fosfomycin (with trometamol) is for treatment of acute uncomplicated lower urinary tract infections, caused by pathogens sensitive to fosfomycin, in women above 12 years of age and for prophylaxis of urinary tract infections in surgical or diagnostic procedures involving the lower urinary tract in adult males and females.
Fosfomycin acts on at the first stage of bacterial wall synthesis. It inhibits the phosphoenolpyruvate transferase enzyme, thereby irreversibly blocking the condensation of uridine diphosphate-N-acetylglucosamine with p-enolpyruvate.
ANN/INN: fosfomycin trometamol
Fosfomycin is not specifically scheduled and is not captured by any entry in the current Poisons Standard.
Trometamol is in Schedule 4 as follows:
TROMETAMOL in preparations for injection except in preparations containing 3 per cent or less of trometamol.
Fosfomycin trometamol is not registered in New Zealand or Canada. In the USA, fosfomycin tromethamine is supplied in an oral suspension (sachet) dosage form to be dissolved in water and is available by prescription only.
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;
- The TGA evaluation report; and
- The new drug application.
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 fosfomycin in Schedule 4, with an implementation date of 1 October 2017.
The delegate has decided that the wording for the schedule entry will be as follows:
Schedule 4 – New Entry
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:
- It is an NCE with no clinical experience in Australia.
- The potential for abuse of fosfomycin is unlikely.