Tapentadol is a centrally acting opioid analgesic with dual mechanisms of action, specifically µ-opioid receptor agonist and noradrenaline reuptake inhibition. This dual action is thought to result in a lower dose required to produce a given level of analgesia. Clinical trials suggest that tapentadol provides equivalent or superior levels of pain relief for acute and chronic pain similar to oxycodone and morphine, with greater gastro-intestinal tolerability in terms of reduced rates of nausea, vomiting, and constipation. The immediate release form of tapentadol is registered in Australia for moderate to severe pain, while the sustained release form is registered for severe pain which requires constant opioid treatment and for which no other opioid other treatments are adequate. Although a sustained-release formulation of tapentadol was released in Australia in 2011, and listed for subsidy on the Pharmaceutical Benefits Scheme in November 2013, no research into rates into dispensing, extra-medical use, and associated harms of the tapentadol sustained-release formulation has been undertaken in Australia.

Project Collaborators External

• Dr Rose Cairns NSW Poisons Information Centre, The Children’s Hospital at Westmead, NSW, Australia; School of Medical Sciences, University of Sydney, Sydney, NSW
• Prof Nicholas Buckley NSW Poisons Information Centre, The Children’s Hospital at Westmead, NSW, Australia; School of Medical Sciences, University of Sydney, Sydney, NSW

Project Supporters

Seqirus (untied educational grant)

Given the broader context of rising rates of pharmaceutical opioid use and harms (including overdose), monitoring new formulations in terms of population level pharmaceutical opioid use, and extra-medical use amongst high risk populations (e.g., those reporting extra-medical use of other pharmaceutical use) is critical.

This study will measure post-introduction: i) population level availability, ii) extra-medical use and diversion, iii) attractiveness for extra-medical use, and iv) associated harms, of tapentadol compared against other pharmaceutical opioids.

Design and Method

Data sources comprise: i) national pharmaceutical opioid community sales data from 2011-2017, ii) national pharmaceutical opioid poisonings reported to Poison Information Centres from 2011-2017, and iii) data on pharmaceutical opioid extra-medical use, attractiveness, and harms from interviews with people who inject drugs in Australia.

Progress/Update

Underway

• Paper: Peacock, Amy, et al. "Opioid use and harms associated with a sustained-release tapentadol formulation: a postmarketing study protocol." BMJ open 8.3 (2018): e020006.
• Paper: Peacock, Amy, et al. "Opioid use and harms associated with a sustained-release tapentadol formulation: A post-marketing surveillance study." Drug and Alcohol Dependence (2019): 107697.
• Presentation: Peacock, A., Gisev, N., Memedovic, S. et al. "Opioid use and harms associated with a sustained-release tapentadol formulation: A post-marketing surveillance study”. NDARC Symposium, 2018.
• Presentation: Peacock, A., Gisev, N., Memedovic, S. et al. "Opioid use and harms associated with a sustained-release tapentadol formulation: A post-marketing surveillance study”. APSAD Conference, 2018.
• Presentation: Peacock, A., Gisev, N., Memedovic, S. et al. "Opioid use and harms associated with a sustained-release tapentadol formulation: A post-marketing surveillance study”. APSAD Conference, 2019.