Durect announced that the FDA has issued a Complete Response Letter (CRL) for Posidur (Saber-Bupivacaine), an investigational drug for administration into the surgical site to produce post-surgical analgesia.
Based on the FDA’s review, it has been determined that they cannot approve the NDA in its present form. 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 has indicated that additional clinical safety studies need to be conducted.
Posidur is a post-operative pain relief depot that utilizes Saber technology to deliver bupivacaine to provide up to three days of pain relief after surgery.
For more information call (408) 777-1417 or visit Durect.com.