Cali Biosciences Co., Ltd. has announced two milestones for CPL-01, its long-acting ropivacaine for post-operative analgesia and opioid elimination/reduction.
The company saw the publication of CPL-01, an Investigational Long-Acting Ropivacaine, Exhibits Extended-Release Properties after Mini-abdominoplasty in the Japan Journal of Medicine.
It also gave a presentation of preclinical data at the American Association of Pharmaceutical Sciences’ Pharma 360 annual meeting, confirming the tolerability and duration of CPL-01 in both soft tissue surgery and bony tissue surgery.
Reducing need for opioids
CPL-01 is an extended-release injectable version of Naropin (ropivacaine hydrochloride), developed by Cali Biosciences to treat post-operative surgical pain and reduce or eliminate the need for opioids. The publication in Japan Journal of Medicine confirmed that the trial demonstrated long-acting pain control and opioid reduction, while further supporting the safety and efficacy of CPL-01.
Hanghang “Tommy” Xu, Cali’s head of clinical research for Asia, said, “The benefits of ropivacaine over bupivacaine are well supported in the literature, so the benefits of ropivacaine as the anesthetic of choice in a long-acting analgesic product are self-evident.”
Ira Gottlieb, the principal investigator on the study and a co-author on the manuscript, said: “While long-acting bupivacaines have started to hit the market over the past decade, this is the most advanced long-acting ropivacaine and could be a game-changer.”
No local toxicity
The presentation at the AAPS confirmed that across multiple species and multiple models, in both soft tissue surgeries and bony surgeries, CPL-01 demonstrated extended-release characteristics without evidence of local toxicity.
William Nappier Cherup, presenter of the poster, said: “The assessment of systemic exposure, along with the lack of any signal regarding local tolerance, systemic toxicity, or bone healing supports moving forwards with CPL-01 as a newer, safer long-acting local analgesic.”
Erol Onel, chief medical officer of Cali Biosciences US, LLC, added that several of the recently introduced long-acting local analgesics did not come to market with a broad label and that recent FDA guidance documents from earlier this year support confirming safety, efficacy, and pk in soft tissue and bony models – this is an incredibly important step in the path to helping patients after any surgery recover in an opioid-free manner.
PJ Chen, chief executive officer of Cali Biosciences, said: “CPL-01 is the core product of Cali Biosciences’ product pipeline in our perioperative program, which also includes anesthetics, and long-acting anti-inflammatories. Given our prior successful results, we remain confident that CPL-01 will meet the unmet clinical needs, and provide a new and better option for doctors and patients seeking post-operative pain management – including opioid reduction or elimination. We look forward to serving more doctors and patients worldwide.”
CPL-01 is an extended-release injectable formulation of Naropin (ropivacaine hydrochloride), a member of the amino amide class of local anesthetics indicated for the production of local or regional anesthesia for surgery and acute pain management.
Naropin (ropivacaine hydrochloride) Injection is approved for local or regional anesthesia for surgery and for acute pain management. However, because of the short duration of effect, frequent injections or infusion by catheter are required if protracted local analgesia is required for postoperative pain management.