Trevena’s opioid injection fails to win over FDA committee
pharmafile | October 12, 2018 | News story | Medical Communications, Sales and Marketing | FDA, Trevena, US, oliceridine, opioid, opioid crisis, pharma
Trevena has seen its opioid injection oliceridine fail to win over an FDA advisory panel in the management of acute pain – a hard sell against the ongoing US backdrop of lethal opioid addiction.
The Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) voted 8-7 against the therapy for the management of moderate to severe acute pain where an intravenous (IV) opioid is required, after reviewing full clinical data from two efficacy studies and one safety study emulating real-world use of the drug. In a release confirming the commiuttee’s decision, Trevena said that oliceridine “demonstrated efficacy compared to placebo”.
“We just don’t have enough safety data to say that we are not going to inadvertently harm people,” remarked panel member Mary Ellen McCann, Associate Professor of Anesthesia Harvard Medical School. “If this drug is brought up in another half a year or a year with better, more data, I would be very happy to vote yes.”
Kevin Zacharoff, a panel member who voted in favour of the drug, added: “I did not see anything today to indicate may be it was better than morphine, but I certainly did not feel that I saw anything that made it more dangerous than morphine.”
Accepted for review in January this year, the FDA aims to complete its assessment of the drug and reach a regulatory decision by 2 November. While the agency is not beholden to the verdict of the AADPAC, it will be taken into account and could carry a lot of weight in the final decision.
“We continue to believe that the totality of evidence presented and discussed today supports the utility of oliceridine as a new analgesic option for the management of moderate to severe acute pain for patients in hospitals or other controlled clinical settings,” said Carrie L Bourdow, Trevena’s President and Chief Executive Officer. “Trevena is committed to working closely with the FDA as they complete their review of the NDA for oliceridine.”
Matt Fellows
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