SAN DIEGO, June 25, 2021 /PRNewswire/ -- Neurana Pharmaceuticals, a biotechnology company focused on the treatment of neuromuscular conditions, today announced the acceptance and presentation of a scientific abstract entitled, "The Effects of Tolperisone on Simulated Driving Performance, Drowsiness, and Cognitive Function: Comparison with Cyclobenzaprine and Placebo in a Phase 1, Randomized, 4-Period, Crossover Study" at the 23rd Annual American Society of Interventional Pain Physicians Meeting (ASIPP), which will be presented on June 25th in New Orleans, Louisiana.
The abstract is only one of twelve selected for oral and poster presentation at the conference. The objective of the study was to evaluate tolperisone 200 mg three times per day (TID) and tolperisone 400 mg TID (supratherapeutic dose) over a 3-day period on measures of simulated driving performance, somnolence, cognitive function and safety compared to placebo and cyclobenzaprine (positive control in normal healthy volunteers). The primary endpoint for the study was Standard Deviation of Lateral Position (SDLP) which measures an individual's ability to maintain lane position while driving. The study demonstrated that driving performance on Days 1-3 did not significantly differ in subjects receiving tolperisone 200 and 400 mg TID versus placebo. In contrast, SDLP was significantly worse for cyclobenzaprine, the active control, versus placebo on Days 1-3. There were no significant differences in self-reported sleepiness in subjects receiving tolperisone 200 and 400 mg TID versus placebo. Somnolence rates were similar between tolperisone 200 mg TID, tolperisone 400 mg TID, and placebo at 0, 2 (5.3%) and 1 (2.8%), respectively. Alternatively, somnolence rates for subjects receiving cyclobenzaprine were higher (25.0%). There were no significant differences between subjects who received tolperisone 200 or 400 mg TID versus placebo in all three cognitive function assessments (Reaction Time, Rapid Visual Information Processing, and Digit Symbol Substitution Test).
"The published clinical data continues to demonstrate the potential benefit of tolperisone in the treatment of acute and painful muscle spasms without causing drowsiness or impacting cognitive function," explained lead author Gary Kay, PhD, President and Chief Scientific Officer of Cognitive Research Corporation, Clinical Research Organization of the study. "Tolperisone was comparable to placebo across all key study measures: driving performance, self-reported sleepiness, cognitive function, and rates of somnolence adverse events. These findings significantly differentiate tolperisone from all other currently available skeletal muscle relaxants."
The abstract will be available for viewing at www.neuranapharma.com.
About Neurana Pharmaceuticals, Inc.
Neurana Pharmaceuticals, Inc. is a privately held, clinical-stage, biotechnology company focused on the treatment of neuromuscular conditions, including acute, painful muscle spasms of the back. The company was founded in 2013 and is based in San Diego. Neurana's lead development compound is tolperisone, a novel, non-opioid, non-drowsy, non-cognitive impairing treatment, which the company is developing for the large population of patients who experience muscle spasms. In May 2018, Neurana completed a $60 million Series A financing led by Sofinnova Ventures with participation from Longitude Capital, New Leaf Venture Partners and H.I.G. BioHealth Partners to fund the clinical development of tolperisone. For additional information, please visit www.neuranapharma.com.
SOURCE Neurana Pharmaceuticals, Inc.