Bupivacaine
DURECT Announces Submission of New Drug Application for POSIDUR™ (SABER®-Bupivacaine)
“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 and result in extended hospital stays.”
We expect that the FDA will notify us whether our NDA submission has been accepted for filing within 74 days of submission, which the FDA bases on their initial 60-day review of the completeness of our application. If accepted for filing, the FDA would be expected to assign a PDUFA date of 10 months after the submission.
About POSIDUR
POSIDUR is a post-operative pain relief depot that utilizes DURECT’s patented SABER®technology to deliver bupivacaine to provide up to three days of pain relief after surgery. We are in discussions with potential partners regarding licensing development and commercialization rights to POSIDUR, for which we hold worldwide rights.
About DURECT Corporation
DURECT is a specialty pharmaceutical company developing innovative drugs for pain and other chronic diseases, with late-stage development programs including REMOXY®, POSIDUR™, ELADUR®, and TRANSDUR®-Sufentanil. DURECT’s proprietary oral, transdermal and injectable depot delivery technologies enable new indications and superior clinical/commercial attributes such as abuse deterrence, improved convenience, compliance, efficacy and safety for small molecule and biologic drugs. For more information, please visit www.durect.com.
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