FDA reviewers doubt benefits of Trevena's analgesic over morphine

Trevena Inc. (NASDAQ:TRVN) was off $1.91 (64%) to $1.07 on Tuesday after FDA reviewers expressed doubts that the company’s Olinvo oliceridine (TRV130) offered a benefit over morphine, according to briefing documents released ahead of a planned advisory committee meeting.

In "the most clinically relevant" efficacy analysis of two Phase III studies, the reviewers wrote, morphine led to significantly greater reductions in pain intensity than both doses of Olinvo for which Trevena is seeking approval. The reviewers wrote that FDA "did not agree with Trevena's proposed endpoint" intended to show Olinvo's superiority to morphine with regard to respiratory safety burden "due to concerns with its clinical meaningfulness." They wrote that none of the studies' Olinvo treatment arms showed a significant reduction in the expected cumulative duration of respiratory safety events compared with morphine...