FDA, Regulatory

Trevena crushed as analysts count red flags in FDA’s review of its new pain med

The FDA put out its in-house assessment of Trevena’s new pain med, now up for review, and at first blush it’s not looking good for the biotech today.

In an assessment of the drug’s efficacy and safety, insiders tagged Trevena’s treatment for a mixed set of data that highlighted how morphine often produced better pain relief for the target patient population. The biotech’s opioid, furthermore, has “high abuse potential,” according to the FDA, raising a red flag for analysts who have watched lawmakers and the FDA organize a nationwide campaign against opioid abuse.

Investors added up the warnings, and beat a hasty retreat. Trevena’s shares $TRVN lost more than half their value in a short time, with most betting against the biotech at their upcoming outside panel review this week.

Trevena was cited by the FDA on the trial design, chided for creating an endpoint on the comparative respiratory safety burden of their drug and morphine — which has well documented problems on that score — uncertain over its clinical meaningfulness.

(W)hen evaluating this endpoint in both studies, none of the oliceridine treatment arms demonstrated a significant reduction in the expected cumulative duration of respiratory safety events compared to morphine. Further, any numeric trends in terms of respiratory safety must be considered in the context of the observed efficacy.

The FDA called out the drug for causing adverse events, including “hepatic adverse events and QT prolongation.” 

Efficacy was also a mixed bag, with morphine significantly outperforming their drug at key doses.

In FDA’s analysis for Study 3002, two of the three doses of oliceridine (0.35 mg and 0.5 mg) demonstrated a statistically greater reduction in pain intensity than placebo, but the 0.1 mg dose did not. In Study 3002, morphine demonstrated a greater reduction in pain intensity relief than two of the doses of oliceridine (0.1 mg and 0.35 mg) that was statistically significant. The reduction in pain intensity by morphine was not greater than that of the highest oliceridine dose (0.5 mg). Currently, Trevena is only seeking approval of the 0.1 mg and 0.35 mg doses.

There have been questions circulating about this drug, their data and the company as a whole since early 2017, when analysts first started questioning the Phase III results and the way it stacked up — or didn’t — against morphine. The company was forced to undergo a painful restructuring and the CEO, Maxine Gowen, officially stepped down at the beginning of this month.

It’s not unusual for in-house reviews to take the most skeptical view of a drug, but Trevena appears to have fallen well short of the kind of grade needed to win over outside experts on Thursday. We’ll see what the experts say, leaving the FDA to come to a final decision. But Trevena is fighting an uphill battle.


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Biotech Investment Analyst
SV Health Investors Boston, MA
Research Scientist - Disease Biology
Recursion Pharmaceuticals Salt Lake City, UT
Senior Scientist - Predictive Pharmacology
Recursion Pharmaceuticals Salt Lake City, UT
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Cadent Therapeutics Cambridge, MA
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twoXAR Mountain View, CA

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