Novartis partner Durect registers a PhIII pain drug flop, biotech’s shares crater
Eighteen months after the FDA ordered Durect$DRRX to amend its Phase III study of its pain drug posimir, the biotech is reporting that the therapy flopped — and the protocol change may have played a key role in the failure.
The agency demanded that Durect add bupivacaine as a comparator drug in the Phase III trial of its extended-release version of the drug. Only the top-line demonstrated that there was no statistical difference in patient response for the endpoint: Reduction in pain on movement in the first 48 hours after surgery.
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