FDA approves Pfizer’s Troxyca ER extended-release capsules for pain management

The capsules are intended to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are not sufficient.

Troxyca ER extended-release capsules have pellets that feature oxycodone hydrochloride opioid agonist, which surround sequestered naltrexone hydrochloride, the other opioid antagonist.

After taking as directed, the naltrexone remains sequestered and patients receive extended-release oxycodone.

Studies showed that when the pellets are crushed, the sequestered naltrexone is released which counteracts the effects of oxycodone.

Two FDA advisory committees recently backed the approval of Troxyca for severe pain management.

Pfizer chief medical officer of internal medicine Rory O’Connor 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.

“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.”

Pfizer warned that Troxyca ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can result in overdose and death.

The company noted that patient’s risk should be evaluated before prescribing Troxyca ER, and they should be monitored regularly for the development of the above mentioned behaviors or conditions.

Image: Pfizer World Headquarters New York City. Photo: courtesy of Norbert Nagel, Mörfelden-Walldorf, Germany.