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Scheduling delegate's final decisions, March 2017
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 silodosin, a new chemical entity (NCE) for a human therapeutic medicine.
Silodosin is an alpha-adrenergic blocker that blocks alpha1A adrenoreceptors in the prostate gland, bladder, urethra and blood vessels. When these receptors are activated, they cause the muscles controlling the flow of urine to contract. By blocking these receptors, silodosin allows these muscles to relax, making it easier to pass urine and relieving the symptoms of benign prostatic hyperplasia (BPH).
Silodosin is indicated for the relief of lower urinary tract (LUTS) associated with BPH in adult men.
Australian Approved Name (AAN) and International Non-Proprietary Name (INN): Silodosin
Silodosin is not specifically scheduled and is not captured by any entry in the current Poisons Standard.
Silodosin is not classified in New Zealand.
Silodosin is a prescription only medicine in Canada, the USA and EU.
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 silodosin in Schedule 4, with an implementation date of 1 June 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:
- Silodosin is an NCE with no clinical experience in Australia.
- The risks and benefits of Silodosin have been considered and are outlined in the Product Information, Delegate's Request for ACM advice and the TGA evaluation reports
- Silodosin has no previous experience of use in Australia but has been available for several years internationally.
- Silodosin is proposed for use in the hospital and community. However the majority of use will be in the community.
- Treatment should be initiated by a medical practitioner. Silodosin has risks that require medical intervention, evaluation and monitoring by a medical practitioner.
- Labelling needs to comply with the requirements for a prescription only medicine.
- It does not appear to produce dependency and the abuse potential appears to be low.