Information on Buprenorphine sublingual tablets

Thank you for your request dated 20 February 2024 under the Official Information Act 1982 (OIA) for information relating to buprenorphine sublingual tablets. You requested:

Can I please documentation related to the buprenorphine sublingual tablets (Temgesic) Pharmac appraisal, pursuant to the official information act. Namely:

• Application
• Clinical advice paper
• Committee meeting minutes
• Technical assessment report

We can advise that in 2014 Pharmac received an application for buprenorphine sublingual tablets. This application is released to you in full.

This application was not progressed further in our assessment process due to buprenorphine sublingual tablets (temgesic) not being registered with Medsafe. This decision was noted by the Pharmacology and Therapeutics Advisory Committee (PTAC) in their February 2015 meeting minutes. The relevant extract is released to you below in full:

Extract Record of PTAC meeting 12 & 13 February 2015

Buprenorphine

4.9. The Committee noted a funding application from a clinician for buprenorphine sublingual tablets (Temgesic) for acute pain. The Committee noted that the product was not registered at this time and considered PHARMAC’s response, detailing the reasons for not progressing the application, to be appropriate.

As this application was not progressed, there is no clinical advice paper, committee meeting minutes or technical assessment report. As such, these parts of your request are refused under s18(e), document does not exist.

We trust that this information answers your queries. Please note, you have the right to make a complaint to the Ombudsman about our response to your OIA, under section 28(3) of the OIA. Details of how to make a complaint(external link) are on the Ombudsman’s website.

To make information more freely available, we publish selected OIA responses (excluding personal details) on our website. Please get in touch with us if you have any questions about this.