A new benefit-risk study published in the BMJ Evidence Based Medicine has deemed a new implant preventing withdrawal symptoms for patients with opioid dependency more favourable than sublingual tablets.
Undertaken by the Drug Safety Research Unit (DSRU) in Southampton, the research demonstrated 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.
In the study, the 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 researchers noted that this was when looking specifically at benefits and risks of the mode of delivering the drug buprenorphine, not the general risks and benefits of the drug itself.
While the opioid epidemic in the USA is well documented, Europe also has an estimated 1.3 million high-risk opioid users, in which buprenorphine can be used as a substitution drug for opioid dependency.
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.”
The European Medicines Agency (EMA) requested a systematic benefit-risk assessment to compare buprenorphine implant to sublingual buprenorphine as part of the EU license application.
