Neurana Pharmaceuticals Completes Patient Enrollment in Phase 3 RESUME-1 Study
SAN DIEGO, Calif., November 29, 2021 -- Neurana Pharmaceuticals, a biotechnology company focused on the treatment of neuromuscular conditions, today announced it has completed enrollment of its 1,000 patient Phase 3 RESUME-1 Study of tolperisone for the relief of muscle spasm associated with acute, painful musculoskeletal conditions. Neurana anticipates reporting topline data in the first quarter of 2022.
Randall Kaye, M.D., Chief Medical Officer of Neurana, commented, "We are very pleased to accomplish this significant clinical milestone and look forward to releasing topline data in the coming months. This Phase 3 study is a vital component of the clinical program for tolperisone and we extend our sincere gratitude to the individuals, physicians, site investigators and other personnel who participated in the study."
Neurana launched its Phase 3 RESUME-1 Study in December 2020. The double-blind, randomized, placebo controlled clinical trial was designed to assess the safety and efficacy of tolperisone for the relief of muscle spasm associated with acute, painful musculoskeletal conditions in 1,000 patients. Patients were equally randomized to receive placebo or tolperisone 50 mg, 100 mg, or 200 mg administered three times per day for 14 days. The primary endpoint was patient reported pain at day 14 due to acute back spasm as measured by the Numerical Rating Scale, which uses a scale of 0 to 10, where 0 equals no pain and 10 equals worst pain imaginable. Secondary endpoints include assessing time to onset of action, Clinician Global Impression of Change (CGI-C), and Patient Global Impression of Change (PGI-C). Patients that were eligible to participate in the study included those with acute back pain localized below the neck and above the inferior gluteal folds due to acute and painful muscle spasm starting within seven days prior to study entry and at least eight weeks after the last episode of acute back pain.
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, which the company is developing for the large population of patients who experience muscle spasms. For additional information, please visit www.neuranapharma.com.