SAN DIEGO, May 7, 2018 /PRNewswire/ --áNeurana Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the
Tolperisone is approved and widely used in Europe and Asia for the treatment of neuromuscular conditions, and it has been shown to treat these conditions without sedating patients. It has not been available in the U.S. due to an impurity that was higher than ICH Guidelines. Neurana has an exclusive license from Sanochemia AG to develop and commercialize a patented composition of tolperisone which meets ICH Guidelines in North America. In Neurana's recently announced clinical driving simulation study, designed to measure the sedation effects of tolperisone in comparison to cyclobenzaprine (Flexeril«), the leading treatment for acute muscle spasms, and placebo in healthy volunteers using objective and subjective measures, tolperisone demonstrated a sedation effect equivalent to placebo, while cyclobenzaprine demonstrated significant impairment, correlating to a blood alcohol content of greater than 0.05.
"Approximately 65 million prescriptions are written each year for the treatment of acute, painful muscle spasms. However, all approved treatment options have been shown to be sedating in both clinical trials and routine clinical usage," said David F. Hale, Chairman and Interim President & CEO of Neurana. "These sedating effects impact the personal and professional lives of patients, affecting their ability to function and potentially impairing their ability to drive a vehicle when taking skeletal muscle relaxants to treat acute, painful muscle spasms. We believe that tolperisone's potential to treat neuromuscular conditions without sedation addresses a significant unmet medical need. We are gratified by the support of this experienced group of investors as we seek to treat and improve the quality of life for patients with acute, painful muscle spasms and spasticity."
The Company plans to commence a Phase 2 dose ranging clinical trial later this year to further demonstrate the safety and efficacy of tolperisone in subjects with acute, painful neuromuscular spasms of the neck and back.
In conjunction with the financing, David Kabakoff, Ph.D. of Sofinnova Ventures, Dan Becker, M.D., Ph.D. of New Leaf Venture Partners, Alex Zisson of H.I.G. BioHealth Partners, and Josh Richardson, M.D. of Longitude Capital have joined David Hale and Brian Dorsey on the board of directors.
About Neurana Pharmaceuticals
Neurana Pharmaceuticals is a private company focused on the treatment of neuromuscular conditions, such as acute, painful muscle spasms of the neck and back and spasticity. The company was founded by an experienced drug development and commercial team.
Kathy ScottChief Financial OfficerNeurana Pharmaceuticals, Inc.firstname.lastname@example.org
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SOURCE Neurana Pharmaceuticals Inc.
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