BioSeizer - Model TLC599 - Osteoarthritis Pain Management System
From Pipeline - Pain Management
TLC599 is our proprietary BioSeizer® formulation of dexamethasone sodium phosphate (DSP) designed to provide sustained pain management for up to 24 weeks. TLC599 has the potential to enable patients to receive both immediate and sustained benefit from the local delivery of a highly potent and clinically validated steroid that typically has a very short half-life. Our clinical data suggests that we may be able to achieve a best-in-class duration of action for an intraarticular steroid.
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Products Details
In a Phase II trial, a single intraarticular injection of TLC599 resulted in statistically significant and clinically meaningful improvement in pain relief in both the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Visual Analog Scale (VAS) scores compared to placebo from Day 3 all the way through the end of the study at 24 weeks. Over half of the patients in the TLC599 group had a durable response, maintaining at least 30% pain reduction in both WOMAC and VAS pain scores at all visits through the entire 24 weeks.
API
Dexamethasone sodium phosphate
Indication
Osteoarthritis pain
Development Status
Phase III clinical trial ongoing
Advantage
- Potential to rapid pain relief and maintain up to 24 weeks
- Minimized cartilage damage and toxicity
- Improved drug retention in joint
- Flexibility of needle size to allow for future expanded indications into small joints
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