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Neurana Announces Completion of Tolperisone Phase 2 Study Enrollment

June 20, 2019 By americanpharmaceuticalreview

Neurana Pharmaceuticals has completed enrollment in the "STAR Study," a Phase 2 dose ranging study of tolperisone in acute muscle spasms of the back in over 400 patients.

The STAR Study is a double-blind, randomized, placebo-controlled, parallel group clinical study evaluating the efficacy and safety of tolperisone or placebo administered as multiple doses three times a day (TID) in male and female subjects experiencing acute 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), from no pain to worst possible pain. The study was conducted in 38 sites in the U.S., and the first patient was enrolled on February 1, 2019.

"We are very pleased to complete patient enrollment in the STAR Study, and we plan to announce topline efficacy data later this year," said Craig Thompson, President and Chief Executive Officer of Neurana. "We believe tolperisone may provide a better alternative to patients experiencing acute and painful muscle spasms."

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 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 because of its centrally-acting dual voltage gated calcium and sodium channel blocker mechanism of action.

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