The Neurana study was designed as a three-way cross-over study in healthy volunteers that included tolperisone, placebo and the leading market-share product in the category, cyclobenzaprine (Flexeril®), which has been shown to be sedating in clinical use.
The study results confirmed the non-sedative effects of tolperisone in comparison to the active comparator. For the primary endpoint, tolperisone (450 mg total daily dose) was equivalent to placebo, while the active comparator, cyclobenzaprine (30 mg total daily dose), demonstrated significant impairment.
Neurana is planning to commence a Phase 2 clinical trial, in the first quarter of 2018, to evaluate the safety and efficacy of tolperisone in subjects with painful acute neuromuscular spasms. In this clinical trial, subjects will be evaluated for patient-reported response to a 2-week treatment of various doses of tolperisone compared to placebo. Completion of the Phase 2 clinical trial is expected to take approximately one year.
Neurana is the exclusive licensee for tolperisone in North America and other territories from Sanochemia. The licensing agreement provides Neurana the right to develop and market Sanochemia’s proprietary and patent-protected tolperisone formulation in the United States and other licensed territories. Neurana plans to initially develop tolperisone for the treatment of acute, painful muscle spasms as well as for spasticity.
„We are pleased that the Phase I study has been successfully finished. The study results confirm the non-sedating side effects of tolperisone, which differentiates tolperisone from other muscle relaxants currently prescribed." said Christina Abrahamsberg, CSO Sanochemia Pharmazeutika AG.
“Tolperisone, which has a New Chemical Entity status in the U.S., represents a novel approach for the treatment of acute, painful muscle spasms and spasticity for U.S. patients utilizing a unique mechanism of action without sedation, which is a common side effect of other marketed skeletal muscle relaxant products." said Klaus Gerdes, CMO of Sanochemia Pharmazeutika AG.
“We are pleased with the progress that has been made to establish a key differentiating factor in this large market, which now exceeds 60 million annual prescriptions in the United States.” said Jeff Raser, Neurana’s president and CEO.
Tolperisone is a muscle relaxant used for the symptomatic treatment of spasticity. Tolperisone holds a market-leading position in Eastern Europe, Germany and parts of Asia for the treatment of muscle pain and neuromuscular spasms. 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
San Diego, California-based Neurana Pharmaceuticals is a private company founded by an experienced and successful drug development and commercial team. The company is focused on the development of drugs to treat neuromuscular disorders.
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