FDA’s Approval of New Painkiller Highlights U.S. Opioid Addiction
Painkiller addiction is a growing problem in the United States, and consumer advocacy groups fear rates of addition will only increase thanks to the U.S. Food and Drug Administration’s approval of Zohydro — a hydrocodone-based prescription drug that is the latest variant of painkillers called opioid analgesics.
Last October, the FDA approved the drug for “the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate.” The drug will be available to patients in March. The agency also noted that in keeping with updated labeling requirements for opioid analgesics, Zohydro will be labeled with “stronger warnings” that will “more clearly describe the risks and safety concerns” associated with its class of extended-release and long-acting opioid analgesics. As a Schedule II drug, Zohydro, which is manufactured by San Diego-based Zogenix (NASDAQ:ZGNX), will only be dispensed through a physician’s written prescription with no refills.
Still, the warning labels are not protection enough, according to many consumer advocates. A coalition of more than 40 healthcare, consumer, and addiction treatment groups wrote to the FDA on February 26 asking the agency to revoke its approval of the medication. “On behalf of consumer safety organizations, healthcare agencies, addiction treatment providers, community-based drug and alcohol prevention programs, professional organizations, and other groups on the front-line of our nation’s opioid addiction epidemic, we ask you to put the public’s health ahead of industry interests,” wrote to FDA Commissioner Margaret A. Hamburg, M.D. “In the midst of a severe drug epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid.”