News | September 23, 2019
Neurana Pharmaceuticals Announces Positive Topline Results from Phase 2 STAR Study of Tolperisone in Acute Muscle Spasms of the Back
Tolperisone shown to be effective in treating pain due to acute back muscle spasm
• Tolperisone was well-tolerated and did not increase sleepiness over placebo
• STAR Study results enable Neurana to advance tolperisone to Phase 3 clinical studies in 2020
pharmaceutical company focused on the treatment of neuromuscular conditions, today announced positive topline results from the “STAR Study”, a Phase 2 dose-ranging study of tolperisone in acute muscle spasms of the back. The primary objective of the study was to assess the efficacy of various daily doses of tolperisone to determine the dose to be used for the planned Phase 3 clinical program. Overall, the STAR Study demonstrated the efficacy of tolperisone with the 600 mg dose being highly significant (p=0.004) with sleepiness similar to placebo.
“The initial data from the STAR Study are very encouraging as patients randomized to tolperisone experienced pain relief in the study and the tolerability of tolperisone was similar to placebo,” said Craig Thompson, President and Chief Executive Officer of Neurana Pharmaceuticals. “These findings suggest that tolperisone may provide clinical benefit to patients suffering from acute muscle spasms without the drowsiness associated with muscle relaxants currently available on the market. We look forward to discussing the data with the U.S. Food and Drug Administration during an end-of-Phase 2 meeting to support the continued clinical development of tolperisone, with the goal of bringing tolperisone to patients as soon as possible.”
In the STAR Study, tolperisone was generally well tolerated with most adverse events being mild to moderate and no serious adverse events reported during the study. Headache was the only adverse event reported in more than 5 percent of patients. The rates of drowsiness were similar among the tolperisone treatment groups compared with placebo. In addition, a key secondary endpoint showed sleepiness with tolperisone was similar to placebo.
“Given the current medications for the treatment of muscle spasm and pain, tolperisone represents an exciting new development in the relief of painful muscle spasms. There have been no new therapeutic options approved for the treatment of back pain due to muscle spasms in over a decade,” said Dr. David Borenstein, former Medical Director of The Spine Center at The George Washington University Medical Center. “There remains a significant large unmet medical need for patients seeking relief of painful muscle spasms without drowsiness or sleepiness.”
Given the positive results of the STAR Study, Neurana plans to conduct an end-of-Phase 2 meeting with the FDA in the first quarter of 2020 and initiate Phase 3 clinical studies of tolperisone later in 2020.
About STAR Study
The STAR Study is a double-blind, randomized, placebo-controlled, parallel-group Phase 2 study designed to evaluate the efficacy and safety of tolperisone daily doses of 150, 300, 450 and 600 mg or placebo administered three times a day (TID) in male and female study participants experiencing acute back pain due to or associated with muscle spasm. The primary endpoint was subject-rated pain due to acute back spasm using a Numerical Rating Scale (NRS), from no pain to worst possible pain. The study consisted of 415 patients and was conducted at 38 sites throughout the United States.
Tolperisone is a medicine widely prescribed outside of the U.S. for pain due to acute muscle spasms and spasticity. In the United States, tolperisone is being investigated as a novel, nonopioid treatment for acute and painful muscle spasms without sedation, drowsiness or cognitive impairment effects. Tolperisone is expected to have effective analgesic activity in addition to muscle relaxation due to its centrally-acting dual voltage gated calcium and sodium channel blocker mechanism of action.
About Neurana Pharmaceuticals, Inc.
Neurana Pharmaceuticals, Inc. is a privately held biotechnology pharmaceutical company focused on the treatment of neuromuscular conditions, such as acute, painful muscle spasms of the neck and back and spasticity. For additional information please visit www.neuranapharma.com.
For additional information, please contact:
Johnna Hannah, Director, Corporate Development