Trevena announced Thursday that an FDA advisory committee voted 8-7 against recommending approval for its investigational opioid analgesic Olinvo (oliceridine) to manage moderate-to-severe acute pain in adults for whom an intravenous opioid is needed. The FDA is expected to issue a final decision regarding approval of the drug by November 2.
The company noted that its submission was supported by data from the Phase III APOLLO-1 and APOLLO-2 studies, which had met their primary endpoints, although some doses of the therapy were not associated with significant differences in efficacy versus morphine. Trevena said its filing also included results from the late-stage ATHENA trial that was intended to emulate real-world use of Olinvo in a broad spectrum of surgical and medical acute pain conditions. Meanwhile, in documents released ahead of the panel vote, FDA staff questioned whether the therapy has abuse and overdose potential.
Panel member Mary Ellen McCann commented "we just don't have enough safety data to say that we are not going to inadvertently harm people," adding that "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."
CEO Carrie Bourdow stated "we continue to believe that the totality of evidence presented and discussed today supports the utility of [Olinvo] as a new analgesic option for the management of moderate-to-severe acute pain." She said Trevena "is committed to working closely with the FDA as they complete their review of [our filing]."
Trevena described Olinvo as a G-protein biased mu-opioid receptor ligand that potentially has fewer side effects because of its novel mechanism of action that permits more selective targeting of newly discovered pathways. The company's filing seeking approval of the drug was accepted by the FDA in January.
Trevena has awarded a licence to Jiangsu Nhwa Pharmaceutical to develop and market Olinvo in China and has also licenced the drug to Pharmbio Korea for development and commercialisation in South Korea.
Earlier this week, FDA reviewers released a report on AcelRx Pharmaceuticals' Dsuvia (sufentanil), saying the oral opioid analgesic appears to provide no advantages versus currently available treatments. They also highlighted concerns that the drug's small size could result in patients misplacing the medication and subsequent accidental use by others. An FDA advisory committee meeting is scheduled to discuss AcelRx's filing on October 12.
For related analysis, see ViewPoints: FDA reviewers paint bleak picture for Trevena's opioid.
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