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.
Cue the immediate, company-crushing stock plunge of 57%, which leaves Durect planted in penny stock territory.
“We are very surprised and disappointed by these results, which we will be trying to understand more fully over the coming weeks,” said Durect CEO James E. Brown.
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