Testimony Before the FDA’s Drug Safety and Risk Management Committee and Anesthetic and Analgesic Drug Products Advisory Committee Regarding ALO-02 (Oxycodone/Naltrexone)

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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 the combination opioid product ALO-02 because of serious concerns about increased risk of abuse, given its easy manipulability. We also urged that the FDA’s guidance for industry, “Abuse-Deterrent Opioids —Evaluation and Labeling,” be withdrawn and replaced with a regulation more favorable to patients than to opioid makers.