Durect to 'refine the path' of Posidur program

US drugmaker Durect Corporation (Nasdaq: DRRX) says that it has received meeting minutes from its face-to-face meeting with the US Food and Drug Administration on September 23 regarding the Posidur program.

Posidur is an investigational post-operative pain relief depot which is intended to deliver bupivacaine to provide up to three days of pain relief after surgery.

On February 12, Durect received a Complete Response Letter for Posidur from the FDA.  The FDA said it cannot approve the New Drug Application in its present form, stating the NDA does not contain sufficient information to demonstrate that Posidur is safe when used in the manner described in the proposed label. The FDA indicated that additional clinical safety studies need to be conducted