FDA recently approved the only oxycodone with oral abuse-deterrent features.
Pfizer recently launched oxycodone/naltrexone (Troxyca ER) extended-release capsules for treating severe pain.
The medication is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. An FDA panel backed the drug's approval in June.
To help battle the opioid abuse epidemic, Troxyca ER has properties that are expected to reduce abuse when crushed and administered by the oral and intranasal routes. However, abuse of Troxyca ER via these routes is still possible, the company said.
“Public health authorities and regulators have encouraged the development of treatments that are more difficult to abuse, yet offer pain relief to appropriate patients when used as indicated,” said Rory O’Connor, MD, chief medical officer, Internal Medicine, at Pfizer, in a press release. “The development of this medication with abuse-deterrent properties is another example of our ongoing commitment to advancing science and the treatment of patients with pain conditions.”
Troxyca ER extended-release capsules contain pellets that consist of oxycodone hydrochloride, an opioid agonist, which surround sequestered naltrexone hydrochloride, an opioid antagonist. When taken as directed, the naltrexone is intended to remain sequestered and patients receive oxycodone in an extended-release manner.
“Troxyca studies demonstrated that, when the pellets are crushed, the sequestered naltrexone is released and is available to counteract the effects of oxycodone,” Pfizer said.
The abuse-deterrent features of Troxyca ER were demonstrated in a battery of in vitro laboratory studies and 3 clinical abuse-potential studies utilizing crushed Troxyca ER by oral and intranasal routes of administration and the IV route (with simulated Troxyca ER).
Because of the risks of addiction, abuse and misuse with opioids, and because of the greater risks of overdose and death with extended-release opioid formulations, Pfizer advised prescribers to reserve Troxyca ER for use in patients for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient management of pain.
In addition, serious, life-threatening or fatal respiratory depression may occur with use of Troxyca ER. “Monitor for respiratory depression, especially during initiation of Troxyca ER or following a dose increase. Instruct patients to swallow Troxyca ER capsules whole or to sprinkle the contents of the capsule on applesauce and swallow immediately without chewing. Crushing, chewing, or dissolving Troxyca ER can cause rapid release and absorption of a potentially fatal dose of oxycodone,” Pfizer said.
Read more: How FDA aims to support generic opioids