FDA Approves TROXYCA® ER Extended-Release Capsules CII for Pain Management

Pfizer Igea Luca Dezzani

Pfizer Igea Luca Dezzani

August 19, 2016

Pfizer Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved TROXYCA® ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules. These are intended for oral use, CII for the management of pain severe enough to require daily, around-the-clock, and for which alternative treatment options are insufficient. TROXYCA ER has properties that are expected to reduce abuse when crushed and administered by the oral and intranasal routes. Yet, abuse of TROXYCA ER by these routes is still possible.

Rory O’Connor, MD, Chief Medical Officer, Internal Medicine, Pfizer Inc., 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.”

These TROXYCA ER extended-release capsules comprise pellets that consist of oxycodone hydrochloride. It is an opioid agonist which surround sequestered naltrexone hydrochloride, an opioid antagonist. The naltrexone is intended to remain sequestered when taken as directed, and patients receive oxycodone in an extended-release manner. Studies confirmed that when the pellets are crushed, the sequestered naltrexone is released and is available to counteract the effects of oxycodone.



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