Neurana Pharmaceuticals Touts Results of Study Designed to Confirm the Non-Sedative Effects of Tolperisone, a Novel Skeletal Muscle Relaxant.
M2 PHARMA-October 27, 2017-Neurana Pharmaceuticals Touts Results of Study Designed to Confirm the Non-Sedative Effects of Tolperisone, a Novel Skeletal Muscle Relaxant
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- US-based specialty pharmaceutical company Neurana Pharmaceuticals Inc has received successful top-line results from a clinical trial designed to confirm the non-sedative effects of tolperisone, the company said.
The Neurana study was designed as a three-way cross-over study in healthy volunteers that included tolperisone, placebo and the leading market-share product in the category, cyclobenzaprine (Flexeril), which has been shown to be sedating in clinical use.
This study used a driving simulation trial design acceptable to the US Food and Drug Administration, and assessed various measures of cognition and sedation including both objective and subjective measures.
The primary endpoint for the study was Standard Deviation of Lateral Position, a driving performance measure that is highly correlated to blood alcohol levels.
On Day 1 at Tmax, tolperisone (450 mg total daily dose) was equivalent to placebo (p=0.9) for the primary endpoint of SDLP, while cyclobenzaprine (30 mg total daily dose) demonstrated significant impairment (p=0.05.
On the morning of Day 2 predose, which assesses the next day residual effects ("hangover"), tolperisone was no different than placebo (p=0.7) for SDLP, while cyclobenzaprine demonstrated significant impairment (p=
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|Date:||Oct 27, 2017|
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