A new opioid dependency implant to prevent withdrawal symptoms has been deemed more favourable than sublingual tablets, according to a new benefit-risk study published in the journal BMJ Evidence Based Medicine.
The research into the new opioid dependency implant to prevent withdrawal symptoms, carried out by the Drug Safety Research Unit (DSRU) in Southampton, showed that delivering buprenorphine by subcutaneous implant, rather than in tablet/film-form under the tongue, was favourable in terms of compliance and convenience, quality of life measures and reduced illicit opioid-use.
It showed these benefits outweighed the risks of having the implant including infection at the insertion site, migrated or missing implants, allergic reactions and clinically significant implant breakages. The study looked specifically at benefits and risks of the mode of delivering the drug buprenorphine, not the general risks and benefits of the drug itself.
Professor Saad Shakir, Director of the DSRU, said: “This publication explains how a semi-quantitative benefit-risk tool is used to support risk management and provides more robust evidence than the conventional method.”
While the opioid epidemic in the USA is well documented, Europe also has an estimated 1.3 million high-risk opioid users. Buprenorphine can be used as a substitution drug in patients with opioid dependency. The European Medicines Agency requested a systematic benefit-risk assessment to compare buprenorphine implant to sublingual buprenorphine as part of the EU licence application.
DSRU researchers used the Benefit-Risk Action Team (BRAT) framework, which follows the structured format of a qualitative framework but allows flexibility in choice of quantitative assessment for the study. Researchers used existing data from clinical trials and observational studies to assess benefit-risk.
The DSRU team conducts benefit-risk assessments on medicines at the stage of marketing authorisation. Its bespoke protocols are designed to satisfy regulatory requirements and answer any specific questions from the European Medicines Agency or other regulator.
DSRU is an independent and internationally renowned research unit that monitors, studies and communicates the safety and risk management of medicines.