| 3 min read
Register for free to listen to this article
Listen with Speechify
0:00
3:00
SAN DIEGO—Neurana Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the treatment of neuromuscular conditions, announced early this morning the completion of a $60 million Series A financing to further develop tolperisone, a novel, patented skeletal muscle relaxant for the treatment of acute, painful muscle spasms and spasticity without sedation. The financing was led by Sofinnova Ventures and included participation from New Leaf Venture Partners, H.I.G. BioHealth Partners, Longitude Capital and MagnaSci Ventures.
 
According to Neurana’s website, “Tolperisone is a novel therapeutic compound that has been shown in clinical studies to be safe and effective in the treatment of significant musculoskeletal conditions, including neuromuscular spasms and spasticity. Through wide commercial usage and clinical studies, it has been shown that tolperisone is non-sedating, a key differentiating feature from products that are currently marketed in the US, including cyclobenzaprine.”
 
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 both 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.”
 
Neurana Pharmaceuticals 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.
 
“Tolperisone is a clinical stage product ready to enter Phase 2 clinical trials. The Company has completed a clinical study to confirm the non-sedative properties of tolperisone using a driving simulation study. With the completion of this study, the Company is planning to commence Phase 2 clinical trials, which are expected to be completed within one year,” Neurana’s website notes. “The subsequent Phase 3 clinical program will be a a 2-week trial designed to establish safety and effectiveness in patients with neuromuscular spasms, and is expected to complete within one year. This will serve as the basis for a New Drug Application (NDA) to obtain regulatory approval from the FDA.”
 
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 Neurana’s  board of directors.

About the Author

Related Topics

Loading Next Article...
Loading Next Article...
Subscribe to Newsletter

Subscribe to our eNewsletters

Stay connected with all of the latest from Drug Discovery News.

Subscribe

Sponsored

Reliable fluid biomarkers strategies for clinical neuroscience research

Reliable fluid biomarkers strategies for clinical neuroscience research

Explore how validated fluid biomarker assays advance clinical research for neurological diseases.
Laboratorian with a white coat and blue gloves pipettes green liquid into a beaker with multicolored liquids in beakers and tubes in the blue-tinged, sterile laboratory background.

Discovering cutting-edge nitrosamine analysis in pharmaceuticals

New tools help researchers detect and manage harmful nitrosamine impurities in drugs such as monoclonal antibodies.
A starry night sky reflected over calm water, symbolizing the discovery of hidden patterns in complex systems.

Technology Guide: Spatial biology techniques

Discover essential strategies and expert insights to navigate the expanding world of spatial biology.
Drug Discovery News March 2025 Issue
Latest IssueVolume 21 • Issue 1 • March 2025

March 2025

March 2025 Issue

Explore this issue