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FDA Approves TROXYCA ER (oxycodone hydrochloride and naltrexone hydrochloride) Extended-Release Capsules CII with Abuse-Deterrent Properties for the Management of Pain

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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).
http://www.pfizer.co...
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Occurred on:
Aug 19, 2016
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Related Keywords Troxyca Er, Oxycodone Hydrochloride, Naltrexone Hydrochloride, Extended-release Capsules Cii, Abuse-deterrent, Pain Management