SAN DIEGO, Calif., November 23, 2020 -- Neurana Pharmaceuticals, a biotechnology company focused on the treatment of neuromuscular conditions, today announced the publication of results from the dose-ranging Phase 2 STAR Study of tolperisone in patients with acute and painful muscle spasms of the lower back, in the Journal of Pain Research.
“The published clinical data demonstrates the potential benefit of tolperisone in the treatment of acute and painful muscle spasms,” explained lead author Srinivas Nalamachu, M.D., Adjunct Associate Professor, Kansas City University of Medicine and Biosciences. “The efficacy and favorable tolerability profile, along with no observed impact on somnolence, represents a differentiated profile compared to muscle relaxants currently prescribed for the treatment of muscle spasms.”
The manuscript includes safety and efficacy information for 415 patients (tolperisone n=337; placebo n=78) across 38 clinical sites in the United States. Patients experiencing acute muscle spasm of the back received tolperisone or placebo administered three times per day (TID) for 14 days. Tolperisone was well tolerated with no serious adverse events reported. Overall, adverse events were reported in 18.1% of subjects receiving tolperisone versus 14.1% of subjects receiving placebo. The primary efficacy endpoint was patient-rated pain “right now” using a numeric rating scale on Day 14. Mean change from baseline in numeric rating scale score of pain “right now” on Day 14 was –3.5 for placebo versus –4.2, –4.0, –3.7, and –4.4 for tolperisone 50, 100, 150, and 200 mg TID, respectively.
Randall Kaye, M.D., Neurana Pharmaceuticals’ Chief Medical Officer shared, “We are very pleased to see the tolperisone Phase 2 STAR Study clinical results published in the Journal of Pain Research. This data strengthens our confidence in our planned Phase 3 RESUME-1 study, for which we will begin enrollment imminently and anticipate topline data in the second half of 2021.”
The published data is described further in the manuscript, “Tolperisone for the Treatment of Acute Muscle Spasm of the Back: Results From the Dose-Ranging Phase 2 STAR Study (NCT03802565)”, which can be accessed at https://www.dovepress.com/tolperisone-for-the-treatment-of-acute-muscle-spasm-of-the-back-result-peer-reviewed-fulltext-article-JPR.
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.