Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

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

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.


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. Accessed January 17, 2017.

This Week's Must Reads

Possible Link: Hepatic Steatosis and Brain Aging, JAMA Neurol; ePub 2017 Nov 20; Weinstein, et al

Neurologic Drug Shortages May Compromise Care, Neurology; ePub 2017 Nov 15; Omorodion, et al

Sleep Fragmentation Linked with PD in Older Adults, Mov Disord; ePub 2017 Oct 30; Sohail, Yu, et al

Sleep Apnea Did Not Accelerate Kidney Decline, Sleep; ePub 2017 Nov 3; Canales, Hagen, et al

Dietary Sodium to Potassium Ratio and Stroke Risk, Stroke; ePub 2017 Oct 10; Willey, Gardener, et al

Must Reads in FDA Actions

FDA Clears Apple Watch Heart Rate Accessory, PharmaLive news release; 2017 Nov 30

FDA Approves Soliris for Generalized MG, Alexion news release; 2017 Oct 23

FDA Approves Lyrica CR Extended-Release Tablets CV, Pfizer news release; 2017 Oct 12