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Pfizer Inc announced that the U.S. Food and Drug Administration (FDA) has approved Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules, for oral use, CII 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. 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 by these routes is still possible. It is the only oxycodone with oral abuse-deterrent features described in the labeling.
“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, Pfizer Inc. “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. Studies demonstrated that when the pellets are crushed the sequestered naltrexone is released and is available to counteract the effects of oxycodone.
The abuse-deterrent features of Troxyca ER were demonstrated in a battery of in vitro laboratory studies and three clinical abuse-potential studies utilizing crushed Troxyca ER by oral and intranasal routes of administration and the IV route (with simulated Troxyca ER).
Indication
Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) Extended-Release capsules, for oral use, CII is a combination opioid agonist/opioid antagonist product 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.
Troxyca ER is contraindicated in patients with:
Significant respiratory depression
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
Known or suspected gastrointestinal obstruction, including paralytic ileus
Hypersensitivity (e.g., anaphylaxis) to oxycodone or naltrexone or any other components of the Troxyca ER formulation
About Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com.
