This is the first epidemiological study to examine the public health impact of a tamper resistant extended-release oxycodone (ORF). ER oxycodone was reformulated with physicochemical barriers to crushing and dissolving intended to reduce abuse through non-oral routes of administration. Manufacturer shipments of original ER oxycodone stopped on August 5, 2010, and ORF shipments started August 9, 2010. During the first 20 months following ORF introduction, it was abused significantly less than the original ER oxycodone when measured by 8 outcome measures, particularly through non-oral routes of administration that require tampering (such as injection, snorting, smoking).
More information on this study can be found in the article, "Abuse rates and routes of administration of reformulated extended-release oxycodone: initial findings from a sentinel surveillance sample of individuals assessed for substance abuse treatment" published in the November 2012 issue of the Journal of Pain.
A sentinel surveillance sample of 140,496 individuals assessed for substance abuse treatment at 357 treatment assessment centers across the country between June 1, 2009 and March 31, 2012 was examined for abuse through oral and non-oral specific routes of administration for ER oxycodone before and after ORF was introduced. Significant reductions were observed in eight outcome measures of ORF versus the original ER oxycodone. Data were collected by Inflexxion's proprietary NAVIPPRO® (National Addictions Vigilance Intervention and Prevention Program) system, which includes a network of hundreds of substance abuse assessment centers in the US. The NAVIPPRO data monitoring system tracks prescription opioid and stimulant drug abuse patterns and estimate relative rates of abuse of specific prescription products.
"The study's findings, from the first 20 months following introduction of a tamper-resistant formulation like ORF, suggest that such formulations can significantly impact abuse patterns among a sentinel surveillance sample of individuals assessed for substance use problems," says first author and co-creator of NAVIPPRO, Stephen F. Butler, PhD, Senior Vice President and Chief Science Officer at Inflexxion. "Introduction, on a large scale, of ORF, provided a natural experiment, where abusers and potential abusers were exposed to this new kind of formulation. Since the NAVIPPRO data streams allow nearly real-time observations to be made, we were able to get an initial view of abuse-pattern changes quickly. These findings corroborate results from pre-approval pharmacokinetic and abuse liability studies as well as from laboratory extraction studies that demonstrated reduced abuse potential in controlled environments."
"While abuse of prescription opioids continues to be a significant public health concern, these findings suggest reformulated ER oxycodone thus far has been successful in deterring tampering relative to the original formulation," says co-author Simon Budman, PhD, founder and CEO of Inflexxion. "This study serves as a proof of concept that tamper resistant formulations may help reduce overall abuse and abuse by non-oral routes of administration. Further research is needed to determine whether these effects persist over time and whether similar effects are observed in other populations that abuse or misuse prescription opioids."