Trevena adcom not a vote of confidence

Snippets

Expert advisers to the US FDA gave stronger support to Trevena’s post-surgical morphine alternative, oliceridine, than agency staff did, but yesterday’s 8-7 vote against recommendation is still likely to result in a complete response letter. Trevena's stock, already hammered after the release of briefing documents earlier this week, was down another 25% in premarket trading today. There are also concerns about whether the company misled investors back in 2016, when Trevena said the FDA had agreed key aspects of its phase III trial design – which, it emerged this week, was not the case. The briefing documents stated that clinical trials indicated that morphine provided superior pain control than the two doses of oliceridine under consideration, 0.1mg and 0.35mg on demand, and that oliceridine did not prove itself to be safer on a respiratory endpoint. Advisory committee members who voted in support of Trevana’s application said they were eager to see alternatives to morphine that could help to reduce the risk of opioid addiction in patients. For the FDA to ultimately approve oliceridine, its leadership would have to overrule both the advice of review staff and the advisory committee, which rarely happens.

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