FDA Approves Troxyca ER

Released: 09/06/2016   By: Heidi Dufrene, PharmD

Troxyca ER (Oxycodone/Naltrexone) is a new Schedule II opioid from Pfizer Pharmaceuticals that recently received approval from the FDA (U.S. Food and Drug Administration).
Troxyca ER is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. The new medication will be available in capsule form and could be opened and sprinkled onto food without losing its abuse-deterrent properties. Pfizer’s website states that Troxyca ER capsules are composed of pellets containing Oxycodone, an opioid agonist, which surround sequestered naltrexone, an opioid antagonist. When taken as directed, the naltrexone remains inactive. However, if the capsule is crushed, the naltrexone is released and will counteract the effects of the Oxycodone. The abuse-deterrent properties would be expected to reduce drug availability when crushed and taken by oral or intranasal routes. Pfrizer expects to release Troxyca ER in the beginning of 2017 and it will be available in several strengths.
According to the FDA, current abuse deterrent technology does not prevent all methods of abuse and there is no sufficient evidence that opioids with abuse-deterrent labeling reduces abuse. Current Official Disability Guidelines (ODG) state that extended-release opioids are not recommended as first-line therapy of acute or chronic non-malignant pain. Currently, all long-acting, abuse-deterrent opioids are considered as “N” drugs on the ODG formulary, which means they are not preferred by the ODG organization to initially treat patients.