Clinical Studies to Demonstrate Tolperisone Benefit: Relief from Acute, Painful Muscle Spasms
The Phase 3, RESUME-1 clinical study was initiated in December 2020. The study will enroll ~1,000 patients and will assess tolperisone 50mg, 100mg, 200mg three times per day compared to placebo for 14 days of treatment. Top-line results are expected in Q4 2021.
The Phase 3, RESUME-2 clinical study will initiate following completion of RESUME-1.
PHASE 1: CNS Effects Study
The Phase 1 study, utilizing a validated driving test, confirmed that tolperisone does not impair driving performance. In addition, tolperisone does not appear to cause sleepiness, a side effect often associated with currently available skeletal muscle relaxants.
Tolperisone demonstrated non-inferiority compared to placebo
Cyclobenzaprine exceeded pre-established non- inferiority margin on all three days
PHASE 2: STAR Study
The STAR Study demonstrated that tolperisone was well-tolerated and did not increase sleepiness over placebo. The results enable Neurana to advance tolperisone to Phase 3 clinical studies in 2020.
PHASE 1: Driving Study
The Phase 1 driving simulation study demonstrated that tolperisone was similar to placebo in driving performance. In comparison, cyclobenzaprine, a commonly used muscle relaxant, significantly impacted driving performance. Most individuals on cyclobenzaprine performed similar to those with a blood alcohol concentration above 0.05%, which is considered above the legal limit in most states. In addition, most patients on cyclobenzaprine were unaware of their impairment.
NO IMPACT ON COGNITION WITH TOLPERISONE
In a simulated driving
study, tolperisone performed similar to placebo and with less impairment than cyclobenzaprine
The exact mechanism of action of tolperisone is not fully understood
No binding activity directed to benzodiazepine receptor
No opioid binding activity; no abuse potential
Sodium AND Calcium Bocking Mechanism