Pfizer's ALO-02 is Only an "Abuse-Deterent Opioid" in the Marketing World, Not the Real World Says Public Citizen | Pharma Industry Regulation | Scoop.it

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 We also urged that the FDA’s guidance for industry, “Abuse-Deterrent Opioids —Evaluation and Labeling,” be withdrawn and replaced with a regulation more favorable to patients than to opioid makers.

 

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  • ALO-02 should not be approved because of serious concerns about increased risk and abuse, given its easy manipulability.

  • Current labeling for opioids with potentially abuse deterrent features, as specified in the Guidance, is too lax, literally encouraging companies to put in language that can easily be turned into promotional material increasing, not decreasing, use and abuse.