Cali Biosciences initiated Phase 3 studies of its core product, CPL-01, a long-acting ropivacaine, with dosing in hernia patients already begun and dosing in bunion patients scheduled to start next month.
CPL-01 is an extended-release injectable version of Naropin, developed by Cali to treat post-operative surgical pain and reduce or eliminate the need for opioids.
“We are confident that the Phase 3 results will build on our successful Phase 2 results, and add to the encouraging data we’ve seen so far, so we can provide a new and better option for doctors and patients seeking post-operative pain management, including opioid reduction or elimination, as quickly as possible,” P.J. Chen, CEO of closely-held Cali, said in a statement.
“We have also had successful recent interactions with the FDA regarding two of our preclinical pipeline products, with clear and thoughtful guidelines provided for development of a suite of products that could help serve doctors and patients around the world,” he added.
