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Trevena's Intravenous Opioid Will Face Difficult US FDA Advisory Committee

 
• By Brenda Sandburg

Oliceridine is not superior to morphine, has abuse potential similar to other mu opioid agonists, FDA concludes; also endpoint Trevena used to evaluate respiratory safety was inadequate, FDA says.

An ampoule with opioid. In the background there are still ampoules

Trevena Inc.'s intravenous opioid Olinvo (oliceridine) will need to overcome the US FDA's concerns about the endpoint used to compare its respiratory safety to that of morphine during the product's upcoming advisory committee review.

Like many of the other advisory committee meetings that have considered opioids recently, the session looks like it will be a difficult one for the sponsor

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