Reports Indicate Zohydro is 10 Times More Potent Than Prescription Painkillers Now On Market / Approving Naloxone for Behind-the-Counter Sale Could Help Combat Death from Heroin Overdoes / During Hearing FDA Commissioner Calls Naloxone “Important Medicine” Said Agency is Encouraged By Discussions with Manufacturers to Develop Formulations for Community Use / In Response to Questioning, Commissioners Pledged to Make Progress on Abuse Deterrent Technology
Washington, DC - Today, U.S. Senator Bob Casey (D-PA) pressed Food and Drug Administration (FDA) Commissioner, Dr. Margaret Hamburg, during a hearing of the Health Education Labor and Pensions Committee (HELP) on a newly approved, highly addictive pain killer, Zohydro, and urged the agency to review the status of naloxone, which reverses heroin overdoses, as a prescription drug. Reports indicate that Zohydro is 10 times more potent than prescription painkillers now on the market. Across the country law enforcement and medical professionals have inquired about allowing naloxone to be sold without a prescription to better aid those in need of a lifesaving dose following a heroin overdose. FDA Commissioner Hamburg said that naloxone is an “important medicine” and that FDA is encouraged by discussions with manufacturers to develop formulations of the drug appropriate for community settings. Additionally, the Commissioner pledged to make progress on abuse deterrent technology that could reduce the addictive potential of drugs like Zohydro.
“Families and communities across Pennsylvania have struggled with the disease of addiction. It’s vital that we take steps to help these families, our medical professionals and law enforcement in this effort,” Senator Casey said. “I have serious concern about the FDA’s approval of Zohydro and the impact it could have for those struggling with addiction. I’m also urging the FDA to review naloxone so that those in need of a potentially lifesaving dose can receive it in time.”
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