❓ Question regarding the status of a proposed naltrexone trial in WA prisons. The Minister indicates that a formal research application is required due to TGA restrictions and outlines the process for submission.
AnsweredQoN 5468Legislative Assembly
QuestionView source ↗
I refer to media comments by the Minister that a trial would be considered in Western Australian prisons of naltrexone, and ask has this proposal been advanced and, if so, at what stage is it ? If not, why not?
AnswerView source ↗
Answered
21 June 2016
Responded by
Minister for Corrective Services
Response time
34 days
The Department of Corrective Services (DCS) advises:
Naltrexone implants are not currently authorised by the Commonwealth Therapeutic Goods Administration (TGA) for general use by clinicians in Australia.
The Department of Corrective Services (the Department) has met Dr George O’Neil and representatives of Fresh Start, to explore potential for the provision of Naltrexone implants to prisoners who have opiate addiction.
The Department has advised Dr O’Neil that the appropriate way to progress consideration of a trial of Naltrexone implants in prisons would be to submit a research application through the Department’s research application process for a properly constituted and approved clinical trial. The Department has provided advice as to how to make an application, and remains interested in assessing any application that Dr O’Neil may provide. There would be an expectation from the Department that Dr O’Neil’s proposal would meet the TGA requirements.
Naltrexone implants are not currently authorised by the Commonwealth Therapeutic Goods Administration (TGA) for general use by clinicians in Australia.
The Department of Corrective Services (the Department) has met Dr George O’Neil and representatives of Fresh Start, to explore potential for the provision of Naltrexone implants to prisoners who have opiate addiction.
The Department has advised Dr O’Neil that the appropriate way to progress consideration of a trial of Naltrexone implants in prisons would be to submit a research application through the Department’s research application process for a properly constituted and approved clinical trial. The Department has provided advice as to how to make an application, and remains interested in assessing any application that Dr O’Neil may provide. There would be an expectation from the Department that Dr O’Neil’s proposal would meet the TGA requirements.
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