Neurana Pharmaceuticals Announces First Patient Enrolled in the "STAR Study," a Phase 2 Dose Ranging Study of Tolperisone in Acute Muscle Spasms of the Back
SAN DIEGO, Feb. 4, 2019 /PRNewswire/ -- Neurana Pharmaceuticals, a specialty pharmaceutical company focused on the treatment of neuromuscular conditions, today announced that it has enrolled its first patient in the "STAR Study," a Phase 2 dose ranging study of tolperisone in acute muscle spasms of the back.
The STAR Study is a double-blind, randomized, placebo-controlled, parallel group study of the efficacy and safety of tolperisone or placebo administered as multiple doses three times a day (TID) in approximately 400 male and female subjects experiencing back pain due to or associated with muscle spasm. The primary endpoint is subject-rated pain due to acute back spasm using a Numerical Rating Scale (NRS; 0-10 scale, from no pain to worst possible pain). The study will be conducted across approximately 45 sites in the U.S.
"We are very excited to announce the first patient enrolled in the STAR Study," said Craig Thompson, President and Chief Executive Officer of Neurana. "This marks an important achievement in the U.S. clinical development of tolperisone and furthers our aim of providing patients suffering from acute back pain a novel, non-sedating, non-drowsy, non-opioid therapy."
Additional information about the STAR Study, including eligibility criteria and a list of clinical study sites can be found at www.clinicaltrials.gov (NCT Number: NCT03802565)
Tolperisone is a medicine widely prescribed outside of the U.S. for acute muscle spasms and spasticity. In the U.S., tolperisone is being investigated as a novel, non-opioid, non-sedating, non-drowsy muscle relaxant for the relief of pain due to muscle spasm. Tolperisone is predicted to have effective analgesic activity in addition to muscle relaxation because of 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 specialty 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 us at www.neuranapharma.com.
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SOURCE Neurana Pharmaceuticals, Inc.