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Troxyca ER Approval History

  • FDA approved: Yes (First approved August 19th, 2016)
  • Brand name: Troxyca ER
  • Generic name: naltrexone and oxycodone
  • Dosage form: Extended-Release Capsules
  • Company: Pfizer Inc.
  • Treatment for: Pain

Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) is an extended-release, abuse-deterrent, narcotic analgesic formulation for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.

Troxyca ER capsules are formulated to be abuse-deterrent, and contain extended-release oxycodone pellets with a sequestered naltrexone core. The naltrexone remains sequestered while the capsules are taken as directed. If however, the pellets are crushed, the sequestered naltrexone is released and works to counteract the effects of oxycodone.

Troxyca ER capsules are taken orally every twelve hours. Possible side effects include constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, and abdominal pain.

Development History and FDA Approval Process for Troxyca ER

Aug 19, 2016Approval FDA Approves Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) Capsules with Abuse-Deterrent Properties for the Management of Pain
Jun  8, 2016Pfizer Announces FDA Advisory Committees’ Recommend ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) Extended-Release Capsules for Approval
Feb 13, 2015Pfizer Announces FDA Acceptance for Review of NDA for ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride)

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