Trevena plans to beat a direct path to the FDA after boasting of a pair of Phase III successes for its lead drug, oliceridine, in moderate-to-severe acute pain. But its enthusiasm wasn’t reflected in the brutal beating its shares took early today.
Following up on a heart drug flop last spring, the biotech $TRVN says that their pain drug hit the primary endpoints on batting back pain compared to a placebo in post-surgical patients. But the company hedged its comment on a comparison with morphine, with the higher doses proving non-inferior to morphine and the lower doses falling short of the bar.
Patients in one of the Phase IIIs demonstrated a significantly lower relative effect with a high placebo rate, but the company says it still delivered statistically significant results. Investigators say that the drug also looked considerably safer than morphine, with a lower respiratory safety burden and a reduced need for treating side effects, giving them an edge for patients who are at risk for respiratory and GI side effects.
Trevena CEO Maxine Gowen told analysts this morning that she’s confident in the “impressive and valuable profile” with data that should play well with the FDA as well as payers. “I’m excited about this data.”
Investors didn’t like it, though, possibly unimpressed with the idea that the drug could be reserved for a share of patients while looking at a possible hurdle with payers. And Barclays raised an eyebrow on secondary endpoints.
We were most focused on oliceridine’s secondary endpoints, especially in terms of nausea and vomiting, where the data was more mixed with only positive trends rather than statistical significance across the doses. In this regard, the results were more mixed across both studies.
The biotech’s share price plunged 40% by the end of the day.
Trevena says it will take its drug, which won a breakthrough drug designation, to regulators in Q4.
The drug is being positioned as an alternative to an opioid at a time an addiction crisis has swept through the country. The IV therapy modulates the body’s mu opioid receptors to relieve pain without side effects.
We believe the data for all three dose regimens will support FDA approval of IV oliceridine with a broad indication of management of moderate-to-severe acute pain.
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 37,600+ biopharma pros who read Endpoints News by email every day.Free Subscription