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FDA Accepts Application for Promethazine/ Hydrocodone/ Acetaminophen Painkiller

Approval decision scheduled for January 2017

The FDA has accepted for review a new drug application for CL-108 (Charleston Laboratories/Daiichi Sankyo) for the relief of moderate-to-severe pain while preventing or reducing the associated opioid-induced nausea and vomiting. CL-108 is a fixed-dose, immediate-release, bilayered 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 new drug application for CL-108 was supported by two pivotal randomized, double-blind, placebo- and active-controlled phase 3 clinical studies, one after oral surgery (molar removal) and the other after bunionectomy surgery, as well as by an additional phase 3 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 3 clinical trial program. A human abuse-liability study has also been conducted.

Source: Charleston Laboratories; June 14, 2016.

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