Tiny Treve­na re­turns to FDA in sec­ond bid for con­tro­ver­sial opi­oid painkiller

A year and a half af­ter be­ing re­buffed, mi­cro­cap biotech Treve­na is head­ing back to the FDA in a sec­ond bid to win ap­proval for its opi­oid painkiller.

Treve­na pitched their drug, known as oliceri­dine, as an opi­oid that used dif­fer­ent sig­nal­ing path­ways in the brain and would come with few­er side ef­fects than tra­di­tion­al com­pounds, such as mor­phine. But when the FDA re­viewed the drug in 2018, they came to dif­fer­ent con­clu­sions, say­ing it had “an abuse po­ten­tial, over­dose po­ten­tial and abil­i­ty to pro­duce phys­i­cal de­pen­dence that is sim­i­lar to oth­er mu-opi­oid ag­o­nists.”

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