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FDA Approves Arymo ER for Severe Pain

Egalet news release; 2017 Jan 9

The FDA has approved ARYMO ER (morphine sulfate) extended-release (ER) tablets C-II for the management of severe pain. ARYMO ER is manufactured by Egalet Corporation, based in Wayne, PA.

Indications: ARYMO ER is 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. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, ARYMO ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would otherwise be inadequate to provide sufficient management of pain.

Dosage/administration: ARYMO ER has been approved in three dosage strengths: 15 mg, 30 mg, and 60 mg. For full prescribing information, including the boxed warning and medication guide, visit www.arymoer.com.

Adverse reactions: In clinical trials, the most common adverse reactions with morphine sulfate extended-release formulations were constipation, dizziness, sedation, nausea, vomiting, sweating, dysphoria, and euphoric mood.

Citation:

Egalet receives FDA approval for ARYMO™ ER (morphine sulfate) C-II, an extended-release morphine product formulated with abuse-deterrent properties for treatment of chronic pain. Egalet Web site. January 9, 2017. http://www.multivu.com/players/English/7999051-egalet-corp-arymo-er-fda-approval/. Accessed January 17, 2017.

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