Wien (pta025/24.09.2019/11:21) - Sanochemia Pharmazeutika AG, Vienna (ISIN AT0000776307, ISIN DE000A1G7JQ9), announces positive topline results from the "STAR Study", a Phase 2 dose-ranging study tolperisone in acute muscle spasms of the back, conducted by its partner Neurana Pharmaceuticals Inc. in the U.S.
The STAR Study is a double-blind, randomized, placebo-controlled, parallel-group Phase 2 study designed to evaluate the efficacy and safety of tolperisone in various daily doses 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 study consisted of 415 patients and was conducted at 38 sites throughout the United States.
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 a p value of 0,004 for the 600 mg dose and a very high tolerability of the drug confirming its lack of sedation.
Neurana Pharmaceuticals Inc (Neurana) plans to initiate Phase 3 clinical studies of tolperisone in 2020.
"The positive results of the clinical Phase 2 trial are a major breakthrough for Sanochemia in this project adding substantial value to tolperisone and to the future perspectives of our licensing partnership with Neurana. We are positively looking forward to the Phase 3 trials, NDA and market launch in near future." says Dr Timo Bender, CEO of Sanochemia Pharmazeutika AG.
"The STAR study data suggest that tolperisone may provide clinical benefit to patients suffering from acute muscle spasms without any associated drowsiness or sleepiness which is given with the current medications for the treatment of muscle spasm. We are enthusiastic that tolpersione will enter the Phase 3 program in 2020." says Dr. Christina Abrahamsberg, CSO of 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.
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