“A Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose Multi-Center Phase III Study of the Safety and Efficacy of CL-108 in the Treatment of Moderate to Severe Pain”
January 28, 2013 – Charleston Laboratories, Inc, an emerging specialty pharmaceutical company focused on the research and development of novel pain products that prevent or significantly reduce nausea and vomiting related to opioid analgesics and other pain associated disease states, announced today that patient enrollment has begun for the company’s pivotal Phase 3 clinical trial for its first product, CL-108, for the treatment of moderate to severe pain.
“The initiation of this study marks the culmination of work by many people” said Dr. Bernard P. Schachtel, Chief Scientific Officer of Charleston. “In addition to input by our scientific, clinical and regulatory advisors, the investigators at the research centers where this study is being conducted also contributed to the protocol.” Dr. Schachtel noted in particular the advice of Dr. Elliot V. Hersh, Professor of Oral & Maxillofacial Surgery and Pharmacology at the University of Pennsylvania, where Dr. Hersh is Principal Investigator for the trial. “As exemplified by the enthusiasm and dedication of the many doctors, nurses, study coordinators, and other researchers at our recent Investigators Meeting,” Dr. Schachtel continued, “this study offers the rare and exciting opportunity to research a truly novel indication, the treatment of both moderate to severe pain and the nausea and vomiting commonly associated with its treatment.”
”This day represents a major milestone for Charleston in our quest to develop differentiated and innovative pain products” said Paul Bosse, President and Chief Executive Officer of Charleston. “I am proud of the Charleston team, specifically the critical roles they played in drug manufacturing, regulatory affairs and project management, and Dr. Schachtel’s team of world-renowned scientific advisors and clinical investigators, including the new study instruments which Dr. Schachtel developed for the measurement of nausea. CL-108 is unique,” Mr. Bosse added, “in that it will be the only commercial product that combines an anti-emetic with an opioid to treat moderate to severe pain while significantly reducing and in many cases eliminating opioid induced nausea and vomiting (OINV). Nausea and vomiting are the most common and burdensome side effects of opioid medications and have a significant impact on patients’ lives and the physicians treating these patients. Demonstrating the many values of an opioid medication with less OINV in this Phase 3 study will not only advance the entry of CL-108 into the marketplace but further our development of other Charleston products now in the lab. With our extensive pipeline, Charleston intends to produce different medicines for patients in pain without the distressing symptoms of nausea and vomiting caused by currently available strong analgesics.”
Charleston Laboratories, Inc is a specialty pharmaceutical company focused on the research and development of novel pain products that prevent or significantly reduce nausea and vomiting, the two most burdensome side effects related to opioid analgesics and other pain associated disease states. Charleston’s new products will address Opioid Induced Nausea and Vomiting (OINV), Postoperative Nausea and Vomiting (PONV), Chemotherapy Induced Nausea and Vomiting (CINV), Radiation Induced Nausea and Vomiting (RINV), and Migraine Induced Nausea and Vomiting (MINV). In addition, Charleston is developing other products without acetaminophen to reduce the potential for liver injury and formulations with abuse deterrent technologies designed to curb misuse and abuse. Charleston Laboratories intends to enter into discovery and commercialization alliances with partners motivated to introduce novel pain therapies that eliminate or significantly reduce nausea and vomiting.