US FDA accepts DURECT's NDA for Posidur

DURECT Corp (Nasdaq: DRRX) says that the New Drug Application for its investigational product Posidur (Saber-bupivacaine) has been accepted by the US Food and Drug Administration, indicating that the application is sufficiently complete to permit a substantive review.

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. The Prescription Drug User Fee Act (PDUFA) goal date has been confirmed as February 12, 2014.

Last year, USA-based Hospira (NYSE: HSP) gave notice that it is returning its development and commercialization rights to Posidur in the USA and Canada (The Pharma Letter April 2, 2012. Nycomed, now part of Japanese drug major Takeda Pharmaceuticals (TYO: 4502), bought the exclusive commercialization rights to Posidur for the European Union and select other countries in a deal under which DURECT is eligible to receive future payments from Nycomed of up to $181 million on achievement of defined development, regulatory and sales milestones. DURECT says it is in discussions with potential partners regarding licensing development and commercialization rights to Posidur, for which we hold worldwide rights.