DURECT Announces Submission of New Drug Application for POSIDUR™ (SABER®-Bupivacaine)

New Drug Approvals

 

Bupivacaine

DURECT Announces Submission of New Drug Application for POSIDUR™ (SABER®-Bupivacaine)

 

April 16, 2013

DURECT Corporation  today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational product POSIDUR (SABER^®-Bupivacaine).  POSIDUR is a post-operative pain relief depot that utilizes DURECT’s patented SABER technology to deliver bupivacaine and is designed to provide up to three days of pain relief after surgery.  DURECT submitted the NDA as a 505(b)(2) application.

“We’re extremely pleased to submit this NDA for POSIDUR to the FDA.  If approved by the FDA, POSIDUR will provide a non-opioid alternative treatment option for post-surgical pain,” James E. Brown, D.V.M., President and CEO of DURECT, stated, “Treating post-surgical pain with a true long-acting local anesthetic has the potential benefit of reducing the need for opioids and their associated systemic side effects that can prolong the time to recovery…

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