TLC Announces Part 1 Analysis of TLC590 Phase II Clinical Trial for Postsurgical Pain Management following Bunionectomy
Part 1 of the two-part Phase II clinical trial, conducted in
Key findings from the analysis are as follows:
- Dose linearity and relative bioavailability of TLC590 have been established.
- All three doses of TLC590 were well tolerated, with a safety profile comparable to ropivacaine.
- Most treatment-emergent adverse events (AEs) were mild to moderate in severity.
- There were no treatment-related or serious AEs, and no AEs leading to withdrawal.
- TLC590 228mg is the dose chosen to move forward based on maximum feasible volume for bunionectomy.
“The rapid enrollment of Part 1 allowed us to promptly understand the pharmacokinetics of TLC590 in an orthopedic setting,” commented TLC Chief Medical Officer Dr.
Ropivacaine was developed as the next generation of local anesthetics, after bupivacaine was found to be associated with cardiac side effects. Despite the reduced central nervous system and cardiovascular toxicities of ropivacaine, many anesthesiologists continue to choose bupivacaine for its longer-lasting duration. In-depth conversations with opinion leaders in anesthesiology have indicated a demand for a single product with an improved safety profile that is capable of providing both early as well as prolonged pain relief.
“In our recent communications with regulatory bodies, we received feedback that, although ropivacaine is known to have a better safety profile, bupivacaine is still more commonly used as wound infiltration anesthesia,” commented TLC President
TLC590 is a non-opioid BioSeizer® sustained release formulation of ropivacaine. TLC590 is designed to prolong the retention time of the ropivacaine around the injection site as a drug depot, to simultaneously extend its therapeutic period, and to reduce unwanted systemic exposure. 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. A Phase II clinical trial in patients following bunionectomy is ongoing.
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