Arymo ER Abuse-Deterrent Morphine Approved
January 9, 2017 - The U.S. Food and Drug Administration (FDA) approved Arymo™ ER (morphine sulfate) extended release, manufactured by Egalet Corp. Arymo ER is a schedule C-II drug indicated for managing severe pain that needs constant treatment, and is not controlled by other treatments. The plan is to launch Arymo ER during the first quarter of 2017 as 15mg, 30mg and 60mg extended-release tablets that are designed to resist abuse. The polymer-matrix tablets are difficult to break or crush, and they congeal when exposed to liquids. Arymo ER carries the same boxed warning that is on all opioids -- that taking it may be associated with abuse, addiction, misuse, overdose and death. If used during pregnancy, babies may suffer neonatal withdrawal syndrome; older children who take it accidentally may overdose from this medication. Recommended dosing for patients new to opioid therapy is one 15mg tablet every 8 hours to 12 hours.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.