Charleston Laboratories Announces Completion of Second Phase III Trial
Charleston Laboratories, Inc. recently announced completion of their second Phase III clinical study on CL-108, a novel bi-layered tablet containing 7.5 mg of hydrocodone and 325 mg of acetaminophen with 12.5 mg of immediate-release promethazine.
In this recently completed study, physicians in multiple clinical settings in the US diagnosed patients with flares of osteoarthritis of the knee or hip and monitored their course when they used CL-108.
“Charleston Laboratories, Inc. is announcing the completion of this Phase III open-label safety study because it represents real-life results with clinical relevance for practitioners who care for patients suffering flares of osteoarthritis,” said Mr. Paul Bosse, Charleston Laboratories’ President and Chief Executive Officer. “Charleston Laboratories takes pride in developing medicines like CL-108 that can have a real impact for patients.”
Charleston Laboratories also announced that Dr. Raymond Dionne, Research Professor at the East Carolina University Brody School of Medicine, has been appointed to its Scientific Advisory Board. Prior to his current professorship, Dr. Dionne was a career Scientist at the National Institutes of Health (NIH), one of the premier research institutions in the world.
“It is an honor to have Dr. Dionne on our Scientific Advisory Board,” said Dr. Bernard Schachtel, Chief Scientific Officer at Charleston Laboratories. “He is one of the true scientists in the study of pain and its treatment. He brings a wealth of experience and insight to Charleston Laboratories’ different analgesic research programs.”
“As presented at the Annual Meetings of the American Pain Society,” Dr. Dionne said “the results of Charleston’s first Phase III trial on CL-108 were impressive, demonstrating significant pain relief and reduction of opioid-induced nausea and vomiting. I look forward to working with Dr. Schachtel and the research staff at Charleston Laboratories on CL-108 and the other analgesic products they are developing.”
Charleston Laboratories, Inc. is a privately held, specialty pharmaceutical company focused on the research and development of novel pain products to significantly reduce the burdensome side effects related to opioid analgesics and other products. The company has a strategic collaboration for the development and US commercialization of its novel hydrocodone combination products, including CL-108, which is being studied for the treatment of moderate to severe pain and prevention of Opioid-Induced Nausea and Vomiting (OINV). For more information, visit www.charlestonlabs.com.
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