A driving study (NCT03353922), published in the Journal of Clinical Pharmacy and Therapeutics has demonstrated the tolerability and safety of tolperisone (Mydocalm; Neurana Pharmaceuticals, San Diego, CA). Tolperisone is a centrally-acting muscle relaxant being studied for the possible treatment of acute muscle spasms.
Key findings from this phase 1 3-way randomized blinded, 3-period crossover study include the following.
• Participants who received tolperisone vs placebo experienced no effects on driving performance compared with placebo; in contrast, those who received cyclobenzaprine had significant driving impairment compared with placebo (P <.01).
• Self-reported sleepiness, self-reported motivation, and self-appraised driving performance were not significantly affected by tolperisone compared with placebo; in contrast, those receiving the active control cyclobenzaprine had 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 it was greater for cyclobenzaprine.
"The results from the study provide evidence that tolperisone does not impact driving ability nor cognitive function," said Randall Kaye, MD, chief medical officer of Neurana Pharmaceuticals. "Once efficacy is established, tolperisone may be able to treat individuals without the common drowsiness and impact on cognitive functioning associated with other known skeletal muscle relaxants, potentially representing an important alternative for the treatment of acute muscle spasms," stated Kaye.
Allie Massaro, MD
Michael S. Cartwright, MD, MS, and Hwajin Lee, MD