BioSeizer - Model TLC590 - Local Anesthetic for Post-Surgical Pain
From Pipeline - Pain Management
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.
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Products Details
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.
API
Dexamethasone sodium phosphate
Indication
Osteoarthritis pain
Development Status
Phase III clinical trial ongoing
Advantage
- Non-opioid
- Fast, immediate onset of pain relief
- Potential pain relief of up to 168 hours
- Less cardiovascular and central nervous system toxicity
- Reduced the frequency of administration
- Proprietary manufacturing process to effectively reduce the cost of production
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