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An anticipated 144 million outpatient surgical procedures will be performed in the US by 2023, and the demand for safe and non-addictive pain management is imperative. Most surgical patients experience post-surgical pain, but less than half of these patients receive adequate pain relief. This ongoing discomfort has been shown to negatively affect patient outcomes. Ongoing pain can increase recovery time and lead to longer hospital stays and readmissions, thereby increasing non-reimbursed hospital costs. The current treatment of post-surgical pain may include wound infiltration with local anesthetics combined with the administration of opioid and NSAID analgesics. Opioids are effective but can also cause many undesirable side effects such as sedation, nausea and vomiting, inhibition of bowel function and dependency or addiction, among others. Respiratory depression is a possible life-threatening complication of opioid use. Bupivacaine and ropivacaine are frequently used for postsurgical pain, however, they suffer from a relatively short half-life. Ropivacaine exhibits reduced cardiotoxicity and central nervous system toxicity compared to bupivacaine, and is the active drug in TLC590. In addition to the existing unmet need of extended release ropivacaine for prolonged pain control, adequate immediate pain control can be elusive, with some physicians co-administering non-liposomal, or immediate release, bupivacaine in addition to liposomal bupivacaine to augment post-operative pain control. |
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TLC590 brings sustained release delivery technology to the common anesthetic ropivacaine, with the goal of reducing the frequency of administration for local anesthesia for post-surgical pain. More effective pain relief may also allow patients to avoid the problems of opioid therapies often used for the treatment of post-surgical pain.In a Phase I/II clinical trial in patients following hernia repair surgery, TLC590 demonstrated durable, statistically significant and clinically meaningful improvement over the standard of care through 96 hours. 58.3% of patients who received TLC590 did not use any rescue opioids at all through the duration of the study; among those who did use rescue opioids, time to first postsurgical opioid use was about four times that of the ropivacaine group (standard of care), and mean total opioid consumption was 54% less through 96 hours post-surgery. In a Phase II clinical trial in patients undergoing bunionectomy, TLC590 demonstrated greater reductions in pain than both placebo and bupivacaine through 168 hours, with statistically significant pain relief 0-12, 0-24, 0-36 and 0-48 hours (p<0.05). TLC590 significantly delayed time to first opioid use versus placebo, and total opioid consumption of TLC590 was less than placebo and bupivacaine at every time point through 168 hours. |
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API Ropivacaine |
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DDS Platform |
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Indication Local anesthesia |
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Advantages
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Development Status Phase II clinical trial completed |
