Durect's pain drug fails to clear key hurdle in PhIIb

Just days after signing a $212.5 million U.S. licensing deal with Hospira, Durect (DRRX) reports that its pain drug Posidur--a long-acting version of the anesthetic bupivacaine--equaled an injectable therapy in a Phase IIb trial but failed to demonstrate an ability to reduce patients' use of rescue opioids.

Durect signed up 115 women to test Posidur's ability to manage pain following hysterectomies. The mixed results on its two primary endpoints include the observation that all the treatment groups turned to opioids for a shorter period of time than was anticipated, giving researchers less data than they needed to outline a statistically significant response rate. Durect's European partner, Nycomed, ran the study and has promised up to $181 million in milestones based on an approval in the EU. Nycomed is continuing to enroll patients in a separate mid-stage pain study while Durect is preparing a pivotal Phase III in the U.S.

"The data from this study further supports the CNS and cardiovascular safety profile of Posidur in another surgical model, but when few opioids are taken, it is difficult to show a reduction in opioid use," said Durect CEO James E. Brown.

Durect can't be happy with a mid-stage study that only produces supporting safety data and demonstrates non-inferiority to another therapy already on the market. But its investors seem to be taking the news in stride, with the developer's shares ticking up a bit in after-market trading.

- see Durect's release
- here's the story from the AP

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