Testimony Before the FDA’s Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees Regarding Extended-Release Morphine Sulfate (Arymo)

View as PDF.

In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee, Public Citizen opposed approval of extended-release morphine sulfate (Arymo) because of serious concerns about increased risk of abuse, given its easy manipulability and unsatisfactory performance in oral human abuse likeability studies. We also urged that the FDA’s guidance for industry, “Abuse-Deterrent Opioids—Evaluation and Labeling,” be withdrawn and replaced with a regulation more favorable to patients than to opioid makers.