Clinical Studies to Demonstrate Benefit for Relief from Acute, Painful Muscle Spasms
Two replicate Phase 3 studies, RESUME-1 and RESUME-2, are expected to initiate in the second half of 2020. The goal of the studies is to continue to demonstrate tolperisone's effectiveness in the reduction of pain due to acute muscle spams.
PHASE 1: CNS Effects Study
The key differentiating feature of tolperisone from other muscle relaxant options is the lack of drowsiness and no impairment on cognitive function. The Phase 1 study will assess the effects of tolperisone on measures of drowsiness and cognitive function with the expected commercial dose.
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