FDA to Review New Narcotic Analgesic Combo for Pain
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.