Cali Biosciences Co., Ltd. , a global biopharmaceutical company focused on the research and development of innovative drugs, announced it has initiated a Phase 2b study of its perioperative long-acting analgesic product CPL- 01.
CPL-01 is an extended-release injectable version of Naropin® (ropivacaine hydrochloride), developed by CaliBio to treat post-operative surgical pain and reduce the need for opioids. This Phase 2b clinical trial is the first in a series of MERIT studies (Management of post-op pain and Evaluation of Reduction In Therapeutic opioids), designed to further investigate the clinical advantages of CPL-01 and to compare with those of existing pain management drugs on the market. The MERIT-1 study, focused on inguinal hernia repair, is currently being conducted entirely in the United States.
Dr. Todd Bertoch, an anesthesiologist who has participated in clinical trials of prior long-acting local anesthetics and a principal investigator in this study, said, "This is an important step; ropivacaine is generally considered safer than bupivacaine, and there are no long-acting ropivacaine options currently available to help our patients with their post-operative pain." Dr. Erol Onel, Chief Medical Officer at CaliBio who has developed several other long-acting local anesthetics, agreed, "We need to do all that we can to help patients control or eliminate their post-operative pain, while continuing to chip away at the opioid crisis."
Dr. PJ Chen, Chief Executive Officer of CaliBio, commented, "CPL-01 is the core product of CaliBio's product pipeline in perioperative analgesia, anesthesia, and anti-inflammation drug solutions. The successful enrollment of the first subject in the phase 2b clinical trial is yet another important milestone in CPL-01's R&D progress. Last year, we completed the Phase 2a clinical trial of CPL-01 in the United States. In the study, there were no safety or tolerability issues with CPL-01 based on the PK and safety results. We are confident that CPL-01 will meet the clinical unmet needs and provide a new and better option for doctors and patients post-operative pain management. We look forward to serving more doctors and patients worldwide."
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