Treve­na ham­mered again as the FDA spurns their con­tro­ver­sial pain drug — but Acel­Rx gets a green light

The FDA ev­i­dent­ly man­aged to sur­prise the die-hard sup­port­ers of Treve­na to­day by re­ject­ing their con­tro­ver­sial pain drug oliceri­dine — send­ing their shares $TRVN down 34% in a deep plunge in­to pen­ny stock ter­ri­to­ry.

Ac­cord­ing to the biotech — which gets to out­line what the agency is de­mand­ing ahead of its next re­view — the FDA is de­mand­ing a lot more safe­ty da­ta. That in­cludes more da­ta on QT pro­lon­ga­tion and a big­ger safe­ty data­base for the drug. The “FDA al­so re­quest­ed cer­tain ad­di­tion­al non­clin­i­cal da­ta and val­i­da­tion re­ports.”

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