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news.The US Food and Drug Administration (FDA) has issued a complete response letter for DURECT's Posidur (Saber-Bupivacaine), an investigational drug for administration into the surgical site to produce post-surgical analgesia.
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Based on the review, the FDA has determined that they cannot approve the new drug application (NDA) in its present form, stating the NDA does have sufficient information to show that the drug is safe when used in the manner described in the proposed label.
The FDA has also indicated that additional clinical safety studies are need to be carried out.
Currently, the company is assessing the issues described in the Complete Response Letter and intends to have further discussions with the FDA around them.
DURECT DVM, president and CEO James Brown 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."
Posidur is a post-operative pain relief depot that uses the company’s patented Saber technology to deliver bupivacaine to offer up to three days of pain relief after surgery.
The company is mainly focused in the development of new drugs for pain and other chronic diseases, with late-stage development programs including Remoxy, Posidur, Eladur, and Transdur-Sufentanil.