FDA

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.”

Maxine Gowen, ex-CEO of Trevena

The FDA wasn’t saying no to every new pain drug, though, despite its concerns about the opioid epidemic that has spurred alarm from coast to coast. AcelRx came up with their long-awaited approval for Dsuvia (ARX-04), driving the stock $ACRX up 16%.

Their drug won a lopsided panel review vote, but still drew flak as critics pounced on the introduction of another powerful pain med that could be ripe for abuse. In a statement, FDA chief Scott Gottlieb countered his critics by noting the need for a non-IV opioid as well as the defense department’s demand for a therapy that would be beneficial on the battlefield.

Trevena plans to continue to plug along in search of an OK, but the penny stock price indicates the fierce headwinds they face after the agency’s internal review offered a harsh assessment of the drug’s safety and mixed efficacy results.

A panel review followed up with a vote against approval, offering all the writing on the wall needed for most analysts.

Trevena still faces accusations that the company misled investors about their interactions with the FDA over their development program.

Attorneys at Bernstein Liebhard accused Trevena execs, specifically ex-CEO Maxine Gowen — who stepped down a few days ago — of misleading investors about an end-of-Phase II meeting with the FDA. At the time, they noted, Gowen said in a May 2, 2016 release that she was “very pleased” with the outcome of its discussions with the FDA about oliceridine (TRV130) and that they had reached a general agreement about the Phase III design. The agency, though, outlined some deep problems the FDA had with that study in their review of the drug.


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