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Arymo ER Approval History

Reviewed on Jan 10, 2017 by J.Stewart BPharm
  • FDA approved: Yes (First approved January 9th, 2017)
  • Brand name: Arymo ER
  • Generic name: morphine sulfate
  • Dosage form: Extended-Release Tablets
  • Company: Egalet Corporation
  • Treatment for: Pain

Arymo ER (morphine sulfate) is an extended-release, abuse-deterrent, opioid analgesic formulation for the management of severe pain.

Arymo ER is formulated to give it physicochemical properties intended to deter abuse, including increased resistance to cutting, crushing, grinding or breaking, and the formation of a viscous hydrogel on contact with liquid, making abuse by injection difficult. However, abuse by the intravenous, intranasal, and oral routes is still possible.

Arymo ER tablets are taken orally at the prescribed dose, every 8 or 12 hours. The tablets must be swallowed whole, one at a time, immediately after placing in the mouth with enough water to ensure complete swallowing. Cutting, breaking, crushing, chewing, or dissolving the tablets will result in uncontrolled delivery of morphine that could lead to overdose and death.

Common side effects include constipation, nausea, and sedation.

Development History and FDA Approval Process for Arymo ER

Jan  9, 2017Approval FDA Approves Arymo ER (morphine sulfate) Abuse-Deterrent Formulation for the Treatment of Chronic Pain
Oct 13, 2016Egalet Notified that FDA Will Not Meet PDUFA Goal Date for Arymo ER
Aug  4, 2016Egalet Announces FDA Advisory Committees Recommend Approval of Abuse-Deterrent Arymo ER (Morphine Sulfate)
Feb 29, 2016Egalet Announces FDA Acceptance of New Drug Application for Arymo ER (Morphine Sulfate) Extended-Release Tablets
Dec 15, 2015Egalet Submits NDA for Arymo ER (Morphine Sulfate) Extended-Release Tablets

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