FDA accepts filing of CL 108 (promethazine and hydrocodone and acetaminophen) for the relief of moderate to severe pain.- Charleston Laboratories and Daiichi Sankyo

Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. announced that the FDA has accepted for review the New Drug Application (NDA) for CL 108 (promethazine and hydrocodone and acetaminophen) for the relief of moderate to severe pain while preventing or reducing the associated opioid-induced nausea and vomiting (OINV). CL-108 is a fixed-dose, immediate-release bi-layered tablet with a rapid release layer containing 12.5 mg of promethazine and a second layer containing 7.5 mg of hydrocodone and 325 mg of acetaminophen. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of January 31, 2017.

The NDA for CL-108 is supported by two pivotal randomized, double-blind, placebo- and active-controlled Phase III clinical studies, one following oral surgery (molar removal) and the other after bunionectomy surgery (removal of bunions from the foot), as well as by an additional Phase III open-label, actual use safety study in patients with moderate-to-severe acute pain, or �flares,� associated with osteoarthritis of the knee or hip. More than 1,000 patients have been enrolled in the CL-108 Phase III clinical trial program. A human abuse liability study has also been conducted.

Comment: Hydrocodone is the most widely prescribed medication in the United States, with over 131 million prescriptions annually, but up to 60% of patients suffer side effects of nausea and vomiting, causing a significant burden for patients and prescribers, as well as contributing significant costs to the healthcare system..