In documents released Tuesday ahead of an advisory panel meeting on October 11, FDA staff suggested that Trevena's experimental opioid Olinvo (oliceridine) has abuse and overdose potential, as well as the ability to cause physical dependence. Shares in the drugmaker plunged as much as 66 percent on the news.
Specifically, FDA staff noted that side effects observed in the clinical programme, including respiratory depression and hypoxia, as well as nausea and vomiting, "were consistent with opioid-related adverse events." The agency's analysis also uncovered that a number of the adverse events such as respiratory effects were dose-dependent. "Notable safety issues in the clinical programme included hepatic adverse events and QT prolongation," the staff report added.
Trevena's filing, which seeks approval of Olinvo for use in adults with moderate-to-severe acute pain who require an intravenous opioid, included data from the Phase III APOLLO-1 and APOLLO-2 trials of patients who experienced pain following bunionectomy and abdominoplasty. Data unveiled last year showed that while the studies had met their primary endpoint, some doses of the therapy were not associated with significant differences in efficacy versus morphine.
Trevena submitted Olinvo for FDA approval in November 2017, with the filing accepted for review by the agency early this year. The company claims Olinvo is the first G protein biased ligand of the mu receptor designed to provide intravenous opioid pain relief with fewer associated adverse effects.
To read more Top Story articles, click here.