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Clinical Studies to Demonstrate Benefit for Relief from Acute, Painful Muscle Spasms

CURRENT STUDIES

PHASE 3:

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.

COMPLETED STUDIES

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

DUAL MECHANISM FOR MUSCLE SPASM & PAIN RELIEF

 
 

CONTACT NEURANA

4370 La Jolla Village Drive
Suite 860
San Diego, CA 92122
United States

contact@neuranapharma.com

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