Charleston Laboratories, Inc, an emerging specialty pharmaceutical company dedicated to reducing opioid-induced nausea and vomiting (OINV) in opioid pharmaceuticals, announced today they successfully completed the Exploratory Bioequivalence Study on CL-108, Charleston Labs’ first drug candidate. “These are promising data on our immediate-release low-dose antiemetic,” said Dr. Ray Takigiku, Chief Operating Officer at Charleston Laboratories, “and confirm our progression in the clinical development of CL-108.”
Dr. Bernard Schachtel, Chief Scientific Officer, added, “We are pleased to be moving CL-108 directly into a Phase III efficacy trial. We conducted this exploratory study to examine different pharmacologic and clinical features of CL-108. While the findings need to be demonstrated in controlled clinical trials, the pharmacokinetic data point to the efficacy of an immediate-release low- dose anti-emetic when combined with hydrocodone and acetaminophen for patients with acute moderate to severe pain. We will utilize key results from this and other studies to build our pipeline of opioid pain management products.”
“We have already been approached by biotech companies interested in licensing this novel approach of treating acute pain while reducing opioid-induced nausea and vomiting,” Mr. Paul Bosse, Chief Executive Officer at Charleston Laboratories, continued. “Because this is a common and burdensome medical problem, Charleston Labs will be developing several opioid products to address this unmet patient need.”
All clinical studies for Charleston Laboratories are being overseen by SRC, Inc., a contract research organization based in Jupiter, Florida that is renowned for its clinical trials on patients’ symptoms, such as nausea, a targeted therapeutic endpoint for Charleston Laboratories.