The FDA has rejected Durect's pain therapy Posidur, telling the biotech that investigators didn't provide sufficient data to prove that it could be safely administered. And regulators sent Durect back to the drawing board, instructing the company to do additional safety studies if it still wants to seek an approval for the drug, intended to ease postsurgical pain.
"In the coming months, we intend to work with the FDA to gain more clarity on the next steps that would be required to address the issues cited in the Complete Response Letter," said Durect CEO James E. Brown in a statement.
That wasn't what investors wanted to hear, though. By late morning the biotech's sharess had pluiinged about 25%.
This isn't the first big setback for Durect ($DRRX) on Posidur. Two years ago the program failed an efficacy test in a late-stage study.
Posidur uses Durect's delivery tech to deliver bupivacaine so it can provide up to three days of pain relief following surgery. The small biotech has been scouting for a licensing deal on the therapy, though that task just got considerably harder.
- here's the press release