Item 8.01 Other Events

On January 17, 2020, DURECT Corporation issued a press release announcing that the U.S. Food and Drug Administration's (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) met on January 16, 2020 to discuss the Class 2 New Drug Application (NDA) resubmission for POSIMIR® (bupivacaine extended-release solution). In a split vote on the key question, six advisory committee members voted to recommend that the efficacy, safety, and overall risk-benefit profile of POSIMIR support approval, while six did not support approval based on the information presented. A copy of the press release is attached as Exhibit 99.1 to this Form 8-K and incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits





  99.1   Press Release of DURECT Corporation dated January 17, 2020






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