Neurana Pharmaceuticals Seeks Strategic Alternatives Following Phase 3 Study
SAN DIEGO, Calif., March 22, 2022 -- Neurana Pharmaceuticals, a biotechnology company focused on the treatment of neuromuscular conditions, today announced that the Phase 3, RESUME-1, clinical study of tolperisone for the relief of muscle spasm associated with acute, painful musculoskeletal conditions, failed to meet its primary and key secondary endpoints.
The primary objective of the RESUME-1 Study was to assess the safety and efficacy of tolperisone across three dose groups (50 mg, 100 mg, and 200 mg) administered three times per day in 1,004 patients. The primary endpoint of the study was patient reported pain “right now” at Day 14 as measured by the Numerical Rating Scale (NRS), which uses a scale of 0 to 10, where 0 equals no pain and 10 equals worst pain imaginable. On Day 14, the efficacy of tolperisone did not demonstrate significance as compared to placebo.
Tolperisone was safe and well tolerated with no serious adverse events. Somnolence, a key attribute of tolperisone, was similar to placebo.
Given the results of the RESUME-1 Study, the company’s board of directors has decided to explore all strategic alternatives and has reduced employee headcount and spending. If no strategic alternatives are identified, the company will begin a plan of dissolution.
For more information about Neurana’s clinical development program, please visit http://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. For additional information, please visit www.neuranapharma.com.