DURECT Corp. (DRRX:NASDAQ) announced in a news release that the company's full response to the U.S. Food and Drug Administration's (FDA's) POSIMIR query has been accepted by the agency as a complete class 2 resubmission. The FDA set a PDUFA goal date of Dec. 27, 2019.
"We are pleased that the FDA considers our POSIMIR submission to be complete," DURECT President and CEO James E. Brown said in the release.
In the submission, DURECT addresses the issues raised concerning POSIMIR in the FDA's complete response letter and requests approval of the analgesic drug. "New nonopioid pain products are much needed in the postoperative pain setting, and we believe that POSIMIR could be an important contributor," Brown added.
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