Arymo ER Approval History
- 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
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