Research also showed that individuals intending to misuse the formulation by snorting or injecting it would not be able to get high. The Advisory Committee members had concerns this feature might lead patients to take more of the drug for an analgesic effect and accidentally overdose. One committee member stated that Purdue has created a product with deterrent properties (which is needed), but this product is inferior to the already marketed analgesic.
According to Purdue and the FDA, IR oxycodone is the most abused opioid and single-entity IR oxycodone is also the most prescribed, accounting for approximately 15 million prescriptions in 2014.
At the same Advisory Committee meeting, members voted unanimously in favor of approving Xtampza ER (oxycodone extended-release capsules) for managing pain severe enough to require daily, long-term opioid treatment for which alternative treatments are inadequate.3 The Prescription Drug User Fee Act date is Oct. 12, 2015, completing the new drug application review.
Collegium, the drug’s manufacturer, developed this formulation using its proprietary DETERx abuse-deterrent technology to address common abuse methods, including chewing, crushing, dissolving, taking it orally or snorting or injecting the formulation.
For patients with dysphagia or who require feeding tubes, the drug can be removed from the capsule and sprinkled on food, directly into the mouth or administered through feeding tubes, without compromising its release profile, safety or abuse-deterrent characteristics.
Michele B. Kaufman, PharmD, CGP, RPh, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
References
- van Vollenhoven RF, Fleischmann RM, Furst DE, et al. Long-term safety of Rituximab: Final report of the rheumatoid arthritis global clinical trial program over 11 years. J Rheumatol. 2015 Aug 15. pii: jrheum.150051. [Epub ahead of print]
- Ault A. FDA panel recommends against first IR antiabuse oxycodone. Medscape. 2015 Sep 11.
- Collegium Pharmaceutical. New release: Collegium announces FDA advisory committees unanimously recommend approval of xtampza ER, an abuse-deterrent analgesic for chronic pain. 2015 Sep 11.
