The STAR Study is a double-blind, randomized, placebo-controlled, parallel group clinical study evaluating the efficacy and safety of tolperisone The study involves more than 400 patients suffering from back pain caused by or associated with muscle spasms. The study was conducted at 38 study sites in the U.S.
Neurana Pharmaceuticals Inc. plans to announce topline efficacy study data later this year.
"Completion of patient recruitment is an important step in the development program of tolperisone for the U.S market. We are pleased that our partner Neurana Pharmaceuticals Inc. successfully completed patient recruitment ." Christina Abrahamsberg, CSO, Sanochemia Pharmazeutika AG.
Tolperisone is a muscle relaxant used for the symptomatic treatment of spasticity. Tolperisone shows a unique, double action mechanism that acts on the peripheral neural system as well as on the spinal cord and brain stem to alleviate severe muscle cramps and significantly improve patient mobility. Tolperisone, unlike other marketed muscle relaxant products, has no sedative side effects.
According to FDA requirements only highly pure tolperisone can be used in the U.S. Sanochemia Pharmazeutika AG developed a highly purified form of tolperisone that provides the basis for a patent portfolio, including a Composition of Matter patent, which extends to 2032 in the U.S.
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.