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(Reuters) – US Food and Drug Administration examiners on Tuesday raised safety concerns about Trevena Inc.'s opioid injection in the treatment of acute pain, saying the treatment had potential for abuse and overdose.
The treatment, oliceridine, is aimed at treating moderate to severe acute pain in adult patients for whom an intravenous opioid is warranted.
Critics of FDA staff have reported https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM622730.pdf a global assessment of abuse data from abuse studies that have resulted in Trevena's research in the footsteps of Trevena's research into the victims' footsteps. potential and ability to produce a physical dependence similar to other treatments of this type.
An expert panel of the FDA is expected to decide Thursday on the effectiveness and safety of treatment. Although the FDA is not obliged to follow the advice of its experts, it does so generally.
(Report by Ankur Banerjee in Bengaluru, edited by Anil D & # 39; Silva)
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