Attractiveness of reformulated OxyContin^® tablets: assessing comparative preferences and tampering potential

Abstract

Reformulated OxyContin® (oxycodone HCl controlled-release or ORF) was developed as a tamper and abuse-deterrent product, to reduce the risk of product abuse, misuse and their consequences. This noninterventional single-session study asked participants who were medically-healthy recreational opioid users, aged 18 years and older, to consider how they would use commonly available supplies to tamper with placebo ORF and placebo original OxyContin (OC) tablets, and how they would assess the attractiveness of tampering and abusing ORF tablets, as compared with other opioid formulations. Participants provided information on past opioid use, and they assessed the properties of five nonhypothetical oxycodone products and two hypothetical oxycodone products. Participants provided feedback on tampering preferences, preferred tamper methods for each product, overall tampering potential and product preferences. We had 30 participants (27 males and 3 females; mean age 35 years, range 18-51) complete both the interview and tampering sessions. Participants judged OC as the most attractive, valuable, desirable and most likely to be tampered with, from among all opioid products studied. By contrast, they rated ORF as the least attractive, least valuable, least desirable, and least likely to be tampered with among all the nonhypothetical opioid products studied. These results suggested that recreational drug abusers view ORF tablets as tamper-deterrent products.

Routes of abuse of prescription opioid analgesics: a review and assessment of the potential impact of abuse-deterrent formulations

“…Studies have shown that it is less attractive to recreational drug abusers than the original extended-release formulation. [101,102] Targiniq™ ER (Purdue Pharma LP) was approved in the USA in July 2014. This abuse-deterrent formulation contains oxycodone combined with naloxone -an antagonist that blocks the euphoric effects of oxycodone if the tablet is crushed for snorting or manipulated for injection.…”

“…[94][95][96][97][98][99] A growing body of evidence suggests that introduction of the abuse-deterrent formulation of oxycodone has been associated with decreased rates of abuse and diversion of this opioid analgesic in the USA. [101,[110][111][112][113][114][115][116][117][118][119]. Cost savings have also been reported to be associated with reductions in abuse following the introduction of the abuse-deterrent reformulation of oxycodone in the USA.…”

The ALERRT® instrument: a quantitative measure of the effort required to compromise prescription opioid abuse-deterrent tablets

“…For example, an easily crushed opioid formulation that can be readily prepared for injection within minutes is likely to be preferred over a hardened tablet that resists extraction and takes considerable effort and time to manipulate. In a previous study, 40.0% to 53.3% of participants (experienced users of opioids for nonmedical purposes) stated that they were willing to spend a maximum of 10 minutes tampering with oxycodone (10 or 40 mg) (9). A comparison of two formulations of oxymorphone found that the maximum time participants were willing to spend tampering with the products was approximately 15 minutes (10).…”

“…In addition to Category 1 studies that focus on the "output" of the manipulation effort, the ALERRT instrument was developed to capture information about the "input" (time, effort, and resources necessary to convert the product into an abusable form). If the degree of effort required is perceived by drug users to be onerous, it is possible that this property may in and of itself deter abuse (9,11). In this respect, it is important to note that this dimension is not captured in Category 3 clinical studies designed to evaluate the abuse potential of a new drug.…”

The introduction of a potentially abuse deterrent oxycodone formulation: Early findings from the Australian National Opioid Medications Abuse Deterrence (NOMAD) study

“…Early US studies indicate lower levels of misuse (Havens et al, 2014), attractiveness (Sellers et al, 2013) and street price (Severtson et al, 2013) amongst specific populations and a decrease in OxyContin ® poisonings following introduction of the reformulated product (Severtson et al, 2013). A reduction in national sales of the reformulated product has also been observed (Hwang et al, 2015).…”