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Charleston Laboratories and Daiichi Sankyo Announce Collaboration to Develop and Commercialize Novel, Fixed-Dose Combination Hydrocodone Products for Pain and Opioid-Induced Nausea and Vomiting (OINV) in the US
Date:8/7/2014

JUPITER, Fla., TOKYO, and PARSIPPANY, N.J., Aug. 7, 2014 /PRNewswire/ -- Charleston Laboratories, Inc., through its wholly owned subsidiary LOCL Pharma, Inc., and Daiichi Sankyo announced today that the parties have entered into a strategic collaboration for the development and U.S. commercialization of Charleston Laboratories' novel hydrocodone combination products, including CL-108, being studied for the treatment of moderate to severe acute pain as well as the reduction of Opioid-Induced Nausea and Vomiting (OINV). 

CL-108 combines 12.5 mg of immediate-release promethazine with 7.5 mg of hydrocodone and 325 mg of acetaminophen.  Charleston recently completed a 465-patient phase 3 trial studying the effects of CL-108 as a treatment for moderate to severe acute pain and the reduction of OINV, where CL-108 demonstrated high statistical significance (P<0.01) in both primary endpoints relative to pain reduction and the symptoms of OINV1.

Hydrocodone is the most widely prescribed medication in the United States, with more than 131 million prescriptions annually.2  Opioid-induced nausea affects up to 30 percent of these patients, with approximately 15 percent experiencing vomiting.3   These unwanted side effects can result in poor pain control related to difficulties with compliance or return visits to the physician or the hospital for further treatment.4   As a consequence, OINV poses a significant burden for patients and prescribers, while contributing significant costs to the healthcare system.5 

With this collaboration, Under the terms of the agreement, Daiichi Sankyo, Inc., the U.S. subsidiary of Tokyo-headquartered Daiichi Sankyo Co., Ltd. (TSE: 4568), will be the exclusive commercialization partner for CL-10
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SOURCE Charleston Laboratories, Inc.
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