Neurana Pharmaceuticals Announces Publication of a Driving Study Conducted by CNS Research
May 12, 2020 — Neurana Pharmaceuticals, Inc., a biotechnology pharmaceutical company focused on the treatment of neuromuscular conditions, today announced the publication of a driving study which demonstrates the tolerability and safety of tolperisone in the peer-reviewed Journal of Clinical Pharmacy and Therapeutics.
The publication, “An assessment of the centrally acting muscle relaxant tolperisone on driving ability and cognitive effects compared to placebo and cyclobenzaprine,” reports results from the Phase 1, threeway, randomized, blinded, three-period crossover study.
The study was conducted by CNS Research with Dr. David Walling as Principal Investigator. Please contact Bobbie Theodore at firstname.lastname@example.org if you need resources around FDA requirements for impaired driving assessment. We have state-of-the-art driving simulators at both CNS Research and Hassman Research Institute, collectively Apex Innovative Sciences, and expertise in studying effects of medications on driving.
Key findings described in the Journal of Clinical Pharmacy and Therapeutics publication include the following:
• Study participants who received tolperisone experienced no impact on driving performance compared to placebo; in contrast, participants who received cyclobenzaprine showed significant impairment compared to placebo (P < .01).
• Self-reported sleepiness, self-reported motivation and self-appraised driving performance showed no significant effects for tolperisone compared to placebo. Study participants receiving active control cyclobenzaprine reported increased sleepiness (day 1), decreased motivation (days 1 and 2) and worse driving performance (days 1 and 2).
• The incidence of adverse events was similar for tolperisone and placebo, whereas was greater for cyclobenzaprine.
The full publication can be accessed online at: http://dx.doi.org/10.1111/jcpt.13165