Trevena down 46% premarket ahead of FDA Ad Com for pain med oliceridine

|By:, SA News Editor

Trevena (NASDAQ:TRVN) slumps 46% premarket on increased volume in reaction to the release of briefing materials for Thursday's FDA advisory committee meeting to review and discuss its marketing application of oliceridine for the management of moderate-to-severe pain in adult patients suitable for IV opioid therapy.

The FDA review team believes that oliceridine has high abuse potential. In addition, per page 93 in the FDA document, oliceridine "looks slightly less efficacious" than morphine (0.5 mg dose) but exhibits "similar rates" of dizziness, hypoxia, nausea and vomiting.

A negative vote from the committee appears virtually certain considering the present opioid crisis.

FDA briefing doc

Addendum to FDA briefing doc

Errata to FDA briefing doc

Company briefing doc 

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