(Reuters) – Staff reviewers of the U.S. Food and Drug Administration on Tuesday raised safety concerns over Trevena Inc’s opioid injection to treat acute pain, saying the treatment has an abuse and overdose potential.
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 here 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.
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.
Reporting by Ankur Banerjee in Bengaluru; Editing by Anil D’Silva