FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Advisory Committee Nixes Trevena’s Opioid in Tight Vote

Oct. 19, 2018

An FDA advisory panel narrowly voted not to recommend approval of Trevena’s NDA for oliceridine, an opioid treatment for moderate-to-severe acute pain in adults.

Prior to the 8-7 vote of the Anesthetic and Analgesic Drug Products Advisory Committee, some members flagged insufficient safety data. Mary Ellen McCann, an associate professor of anesthesia at Harvard Medical School, said that her “no” vote was a difficult decision but that the panel didn’t have enough safety data “to say that we’re not going to inadvertently harm people.”  She noted that she would likely support the med if it came before the committee again in a year with more evidence.

FDA representatives said that, compared to placebos, oliceridine demonstrated statistically significant greater pain reduction, with adverse events generally dose-related and consistent with opioid safety profiles. The agency also presented comparisons between the drug and morphine, noting that doses with fewer adverse events than morphine were also less effective than morphine. The agency concluded there was insufficient evidence for a safety advantage compared to morphine.

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