Charleston Laboratories and Daiichi Sankyo announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for CL-108 for the relief of moderate to severe pain while preventing or reducing the associated opioid-induced nausea and vomiting (OINV).
The NDA submission was based on results from two pivotal Phase 3 clinical studies in oral surgery and bunionectomy, and an additional Phase 3 safety study in osteoarthritis of the knee or hip. The companies have also conducted a human abuse liability study for CL-108.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2017 to make a decision on the NDA.
CL-108 is a fixed-dose, immediate-release bi-layered tablet containing 7.5mg of hydrocodone and 325mg of acetaminophen uniquely formulated with 12.5mg of rapid-release promethazine.