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FDA staff raises safety concerns over Trevena opioid drug


FDA staff raises safety concerns over Trevena opioid drug

London: Staff reviewers of the U.S. Food and Drug Administration has recently raised safety concerns over Trevena Inc’s opioid injection to treat acute pain, saying the treatment has an abuse and overdose potential.

Oliceridine is an opioid drug that is under evaluation in human clinical trials for the intravenous treatment of severe acute pain. It is a μ-opioid receptor biased agonist developed by Trevena. The treatment, oliceridine, aims to manage moderate-to-severe acute pain in adult patients for whom an intravenous opioid is warranted.

FDA staff reviewers said the overall assessment of the abuse-related data from studies leads to the finding that Trevena’s oliceridine has an abuse potential, overdose potential and ability to produce physical dependence that is similar to other such treatments.

Trevena Inc is a clinical stage biopharmaceutical company, headquartered in Chesterbrook, Pennsylvania, USA, and is involved in the discovery and development of G-protein coupled receptors biased ligands.

An expert panel to the FDA is expected to vote on the efficacy and safety of the treatment on Thursday. While the FDA is not obliged to follow the advice of its experts, it generally does.



Source: With inputs
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