FDA Advisory Committees Weigh in on New Abuse-Deterrent Opioid Medications
On the heels of the release of the FDA’s guidelines for the development of generic formulations for abuse-deterrent opioid medications, the FDA Advisory Committees have weighed in on several proposed abuse-deterrent opioid medications.
On April 26, 2016, the U.S. Food and Drug Administration (FDA) approved a new long-acting opioid medication designed for the management of severe pain requiring daily continuous treatment. Xtampza ER, an extended release oxycodone capsule developed by Collegium Pharmaceuticals, is the first product to utilize a new technology that prevents the opioid from losing its extended release properties when crushed or chewed. With this new technology, the contents of the capsule can be administered directly through a feeding tube or can be combined with soft foods without the fear of rapid release of the medication. Launch of Xtampza ER, in five dosages equivalent to oxycodone 10mg, 15mg, 20mg, 30mg and 40mg, is planned for mid-2016. A similar product, also developed by Collegium, which combines hydrocodone with the same abuse-deterrent technology, was accepted by the FDA to begin a clinical trial in January 2016. Collegium has indicated they plan to accelerate development of the hydrocodone product, following the clinical trial.
These two wins followed the FDA Advisory Committees vote against recommendation for approval of another abuse-deterrent opioid manufactured by Purdue Pharma, in September 2015. Avidri, an abuse-deterrent immediate release oxycodone formulation, was not recommended for approval by the committees, due to safety, efficacy and financial concerns.
Opponents emphasize that that the FDA is focusing only on those medications which are abused or misused and ignoring the vast numbers of patients who become addicted to opioids simply by taking as directed; however, the FDA has indicated that the development of abuse-deterrent brand and generic medications is simply one part of their overall plan for combatting the rising problem of opioid abuse.