FDA Issues Complete Response Letter For DURECT's POSIDUR
By Cyndi Root
DURECT Corporation announced in a press release that the Food and Drug Administration (FDA) has declined to approve POSIDUR (SABER®-Bupivacaine). The FDA sent a Complete Response Letter responding to DURECT’s application for the investigational drug indicated for post-surgical analgesia. The federal agency said in the letter that it cannot approve the drug because the NDA does not prove that the drug is safe. The FDA indicated that more trials are needed. DURECT President and CEO James E. Brown, DVM said, "In the coming months, we intend to work with the FDA to gain more clarity on the next steps that would be required to address the issues cited in the Complete Response Letter."
Post-Surgical Analgesia
Pain management is an important area of medical practice and receiving more attention in recent years. Managing pain after surgery is practiced so the patient rests comfortably and the surgery is more likely to be effective. 90 million surgeries are performed in the U.S. each year and having effective post-surgical analgesia is a priority. One way to provide pain relief is to inject or apply an anesthetic at the surgical site.
POSIDUR
POSIDUR is an injectable of bupivacaine. It is injected into the surgical site for long-acting relief. The formulation allows controlled release of the drug up to 72 hours. DURECT sees benefits of the drug that include the reduction in narcotic use, opioid side effects, recovery time, hospital stays, and time that hospital staff spend on managing pain.
Clinical Evidence
A total of 1,060 people have participated in 15 POSIDUR trials. Some were treated with POSIDUR, others with bupivacaine HCl solution, and others with a placebo. DURECT filed a pre-NDA in 2012 and communicated with the FDA on various topics including clinical strategy, the drug profile, and product labeling. In 2013, the company filed a 505(b)(2) application. 2014’s Complete Response Letter is in response to the NDA. The FDA said in the letter that it does not have enough safety information about the drug and cannot approve it at this time.
About DURECT Corporation
DURECT is a specialty pharmaceutical company addressing pain management and diseases. The company has proprietary delivery technologies including oral, injectable, and transdermal. These technologies offer promise of decreasing opioid dependence and improving convenience, compliance, and safety.