The US Food and Drug Administration (FDA) has accepted the new drug application (NDA)from DURECT, a specialty pharmaceutical company, for its Posidur (Saber-Bupivacaine) investigational candidate.
Designed to offer up to three days of pain relief following surgery, Posidur uses the company's patented SABER technology to deliver bupivacaine.
DURECT president and CEO James Brown said Posidur will become a non-opioid alternative treatment option for post-surgical pain upon approval from the FDA.
"Treating post-surgical pain with a true long-acting local anesthetic has the potential benefit of reducing the need for opioids and their associated systemic side effects that can prolong the time to recovery and result in extended hospital stays," Brown added.
Furthermore, the company is negotiating with potential partners for licensing development and commercialization rights to Posidur.
