DURECT Corporation (Nasdaq: DRRX)
announced today that the U.S. Food and Drug Administration (FDA) has
notified the Company that its Class 2 NDA resubmission for POSIMIR®
(bupivacaine extended-release solution) will be discussed at a meeting
of the Anesthetic and Analgesic Drug Products Advisory Committee
(AADPAC). The meeting is tentatively scheduled for January 16, 2020. The FDA had previously assigned a user fee goal date of December 27, 2019; a new user fee goal date has not been assigned.
DURECT commissioned the advisory services of Dr. Lee S. Simon
to lead the Company’s preparation efforts to prepare for the advisory
committee meeting. Dr. Simon is a physician and research scientist who
served as the FDA’s Division Director of Analgesic, Anti-inflammatory
and Ophthalmologic Drug Products from 2001 to 2003, and is now a
Principal at SDG, LLC, an FDA advisory firm.
“We look forward to a productive discussion with the advisory committee,” stated James E. Brown,
President and CEO of DURECT. “If approved, we believe that POSIMIR
could help address an important need for new long-acting, non-opioid
pain products in the post-operative pain setting.”
https://www.prnewswire.com/news-releases/durect-announces-fda-advisory-committee-meeting-to-review-posimir-for-the-treatment-of-post-surgical-pain-300929450.html
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