New name, but same old problems for Posimir as FDA hits Durect again

FDA headquarters, Silver Spring, MD

Durect ($DRRX) may have changed the name of its post-pain gall bladder surgery drug from "Posidur" to "Posimir" this year, but this has not stopped its run of bad luck as the FDA has told the Cupertino, CA-based biotech that it must make a number of amendments to its ongoing Phase III Persist trial for the treatment. This includes adding the numbing agent bupivacaine as an active control, which it said in a statement it will now do. This will however add both time and money to complete the trial--but Durect said it believes that a positive outcome from this trial design "would result in a stronger NDA filing and potentially provide commercial advantages". The company is still on the look-out for potential partners for the drug, but this seems increasingly unlikely at this point, and comes after a series of disappointments. At an earnings call held by the company at the beginning of the year, the biotech said it decided to change the drug's name because of the concerns the FDA has had with Posidur. In 2014, the U.S. regulator told the biotech that investigators didn't provide sufficient data to prove that it could be safely administered and would need additional safety studies. This came two years after the program failed an efficacy test in a late-stage study. The Persist trial is a randomized, parallel group, double-blind, placebo-controlled, multicenter trial conducted in the U.S. The primary efficacy and point will be pain intensity on movement over the first three days after surgery. Its shares were down by 7.5% at 11:10 EDT. Release

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