Charleston Laboratories

Charleston Laboratories is a privately held specialty pharmaceutical company focused on developing and commercializing pain relief medicines. The company was founded in 2007 by G. Paul Bosse III, who serves as the President and Chief Executive Officer, and Dr. Bernard P. Schachtel, who is the Chief Scientific Officer. The inspiration for the company came from Bosse's personal experiences with opioid-induced nausea and vomiting (OINV) following injuries and dental surgery, which was further solidified by his work in the pharmaceutical industry selling pain medication. This led him to conceptualize a novel medication to address this unmet need.

The company's primary focus is on mitigating the side effects of opioid analgesics, particularly nausea and vomiting. Its business model revolves around the research and development of proprietary drug formulations, with a strategy that includes forming strategic collaborations with larger pharmaceutical companies for development and commercialization. A significant partnership was established with Daiichi Sankyo in 2014 for the U.S. development and commercialization of Charleston's hydrocodone products, involving a $200 million upfront payment and potential for an additional $450 million in milestones. The company also seeks to enter into discovery and commercialization alliances with other partners. In 2017, Charleston Laboratories established a wholly-owned U.S. subsidiary, Õlas Pharma, Inc., to handle commercialization activities for its product pipeline.

Charleston Laboratories' lead product candidate is CL-108, a bi-layered, fixed-dose tablet designed to treat moderate to severe acute pain while preventing OINV. This formulation provides an immediate release of promethazine, an anti-nausea agent, followed by a modified release of hydrocodone and acetaminophen for pain relief. The company's pipeline includes other novel formulations combining opioids like oxycodone, hydromorphone, and tramadol with promethazine to address the same issue. Additionally, their research extends to developing products without acetaminophen to lessen the risk of liver injury and creating abuse-deterrent formulations. While CL-108's New Drug Application (NDA) was accepted for review by the FDA in 2016, it received a Complete Response Letter in 2017, indicating it was not approved in its current form. The NDA was resubmitted later in 2017 after Charleston reacquired the commercial rights from Daiichi Sankyo.

Keywords: acute pain management, opioid-induced nausea and vomiting, OINV, pharmaceutical development, drug formulation, CL-108, promethazine, hydrocodone, specialty pharma, analgesic research, antiemetic, pain relief medication, drug pipeline, clinical trials, FDA submission, pharmaceutical partnerships, abuse-deterrent formulations, postoperative nausea