Trevena Shares Plunge As FDA Briefing Document Reveals Pain Drug Concerns

Trevena Inc TRVN has a key catalyst Oct. 11, when the FDA's Anesthetic and Analgesic Drug Products Advisory Committee is scheduled to announce its verdict on the safety, efficacy and benefit considerations for the company's pain medication candidate Oliceridine.

Ahead of the D-day, Trevena shares were slumping 64.25 percent to $1.07 at the time of publication Tuesday.

What Happened

The briefing document released by the advisory committee said Oliceridine is a mu opioid agonist with high abuse and overdose potential and the ability to produce physical dependence that is similar to other mu opioid agonists. 

Oliceridine is being tested for the management of moderate-to-severe pain in adult patients for whom an intravenous opioid is warranted.

"Therefore, it does not appear that the biased agonism of oliceridine with regard to preferential recruitment of G-protein over β-arrestin2 translates into a human safety advantage for oliceridine compared to traditional mu opioid agonists," the document said.

Why It's Important

Oliceridine is Trevena's lead pipeline candidate, with a Nov. 2 PDUFA date. The sell-side has been drumming up the prospects of the pipeline asset garnering the support of the FDA panel, which would increase the probability of FDA giving its go-ahead for the drug.

What's Next

All eyes are on the FDA panel's verdict, which is due Thursday. The FDA, though invariably falling in line with panel recommendations, is not bound to them. 

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