The FDA has declined to approve Trevena’s oliceridine, a mu-opioid receptor modulator for the treatment of moderate to severe pain. The complete response letter comes three weeks after an FDA advisory committee voted narrowly against the drug’s approval.
Oliceridine, given the brand name Olinvo, works differently than conventional opioids, the company says. It uses a different pathway to relieve pain without causing respiratory and gastrointestinal side effects that limit other pain meds.
The FDA was not convinced, saying that Trevena had not submitted adequate safety data to support its proposed dosing. Furthermore, FDA staff outlined in briefing documents released ahead of the advisory committee meeting on Oct. 10 that it has “abuse potential, overdose potential and ability to produce physical dependence that is similar to other (opioids).” The panel came down 8-7 against oliceridine, sending the company’s stock down 64%.
In the complete response letter, the FDA “requested additional clinical data on QT prolongation and indicated that the submitted safety database is not of adequate size for the proposed dosing,” Trevena said in a statement. The agency also asked for additional nonclinical data and validation reports. Trevena’s stock fell more than 30% Friday afternoon.
“While we are disappointed with FDA’s decision, we continue to believe in the strength of the data and the ultimate approvability of oliceridine,” said Trevena CEO Carrie Bourdow. “We plan to schedule a follow-up meeting with FDA as soon as possible with the goal of bringing this important medicine to clinicians and hospital patients.”
Trevena had pinned all of its hopes of oliceridine. In October 2017, the Chesterbrook, Pennsylvania-based biotech axed 21 staffers—30% of its workforce—and stopped all investment in early-stage R&D in order to focus on the pain drug.
“We have decided to reduce our capital needs and focus our resources on the future approval and commercialization of Olinvo, which we believe will be an important new option for physicians and patients,” said Maxine Gowen, the company’s CEO at the time. Gowen has since retired; Bourdow, previously Trevena’s chief operating officer, took over on Oct. 1.
Trevena's rejection comes one day after an FDA panel voted 21-2 against recommending the approval of Alkermes' opioid-containing drug for major depressive disorder.