On January 9, 2017, the US Food and Drug Administration (“FDA”) approved opioid drug Arymo ER (morphine sulfate) manufactured by Egalet US, Inc. (“Egalet”) for use in the management of pain severe enough to require long-term opioid treatment, and where alternative treatment options are inadequate. In its approval, FDA explains that typical post-marketing surveillance of adverse events would be insufficient to wholly assess the risks associated with Arymo ER. FDA will instead require that Egalet perform various prospective, observational studies designed to generally assess and quantify the risk of misuse, abuse and addiction associated with long-term use of opioid drugs for chronic pain management.
While approved, the FDA will not permit that drug labeling for Arymo ER promote that the drug is effective in deterring abuse if snorted or chewed. However, the FDA did sign off on label claims that the drug can deter abuse if dissolved or injected. Extended-release medications such as Arymo ER are considered to be more prone to abuse, which might explain why the FDA has restricted the mechanisms by which the Arymo ER may be promoted in its labeling. Given the growing opioid abuse crisis, it remains to be seen how the FDA may further restrict its approach to approving and labeling such opioid drugs in the future.