Charleston Laboratories & Daiichi Sankyo Announce Completion of Pharmacokinetics Study
Charleston Laboratories, Inc. and its co-development and co-commercialization partner, Daiichi Sankyo, Inc., recently announced the completion of a pharmacokinetics study on CL-108, Charleston Laboratories’ lead product in development.
CL-108 is a tablet containing 7.5 mg of hydrocodone and 325 mg of acetaminophen with 12.5 mg of fast-absorbed promethazine. This novel therapy is being developed as a treatment for moderate to severe pain and the prevention of opioid-induced nausea and vomiting, or OINV.
“This study demonstrated that CL-108 provides comparable bioavailability of hydrocodone, acetaminophen, and promethazine to commercial products,” said Dr. Bernard Schachtel, Chief Scientific Officer at Charleston Laboratories.
“This is encouraging news,” added Mr. Paul Bosse, President and Chief Executive Officer at Charleston Laboratories. “This study confirms the rationale for CL-108. With the clinical results from our first Phase III trial, these bioavailability results help explain why hydrocodone formulated with low-dose promethazine in CL-108 can help manage pain without the debilitating effects of nausea and vomiting that many patients experience from opioid treatment.”
Charleston Laboratories, Inc. is a privately held, specialty pharmaceutical company focused on the research and development of novel pain products to prevent the burdensome side effects related to opioid analgesics and other products. For more information, visit www.charlestonlabs.com.
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, dyslipidemia, and bacterial infections used by patients around the world, the Group has also launched treatments for thrombotic disorders and is building new product franchises. For more information, visit www.daiichisankyo.com.
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