Charleston Labs, Daiichi Sankyo in co-development deal

Charleston Laboratories Inc. (Jupiter, Fla.) and Daiichi Sankyo Co. Ltd. (Tokyo:4568) partnered to develop and commercialize Charleston's fixed-dose combination hydrocodone products to treat pain and opioid-induced nausea and vomiting (OINV) in the U.S.

The deal includes CL-108, a bilayered tablet containing 12.5 mg immediate-release promethazine, an anti-emetic, with 7.5 mg hydrocodone and 325 mg acetaminophen, which has completed a Phase III trial to treat moderate to severe acute pain. Daiichi Sankyo told BioCentury it plans to submit an NDA to FDA by the end of 2015 to treat moderate to severe acute pain while reducing OINV. The application will be submitted under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. ...