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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