Published October 12, 2018
The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 8–7 against recommending approval of IV oliceridine for the management of moderate to severe acute pain in adult patients who require an IV opioid in hospital and similar controlled clinical settings.
Although the FDA is not required to follow the recommendations of advisory committee decisions, historically it almost always does.
“While IV opioid analgesics are needed treatment options, we recognize that we are seeking approval in the backdrop of an opioid crisis,” Maxine Gowen, PhD, founding president and CEO of Trevena Inc., the drug’s manufacturer, said. “While diversion and abuse of IV opioids in controlled settings is relatively low, we believe that any new IV opioid should not expand the population exposed to these medicines or introduce a greater risk for abuse.”
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