SAN DIEGO, Sept. 26, 2017 /PRNewswire/ -- Neurana Pharmaceuticals Inc., a specialty pharmaceutical company focused on the development and commercialization of products that address unmet therapeutic needs of the central nervous system, today announced the completion of enrollment in a clinical trial designed to confirm the non-sedative effects of tolperisone.
The clinical trial is designed as a three-way cross-over study in healthy volunteers that includes tolperisone, placebo and the leading market-share product in the category, cyclobenzaprine, which has been shown to be sedating in clinical use. The study uses a driving simulation trial design acceptable to the US Food and Drug Administration (FDA), and will assess various measures of cognition and sedation including both objective and subjective measures.
This study will be the second U.S. trial to assess the effects of sedation with tolperisone. An earlier trial indicated no difference in sedation vs. placebo when using patient-reported symptoms. The company believes that with two positive U.S. studies assessing the sedative effects of tolperisone, there will be evidence for inclusion in the tolperisone package insert that could make it the only product in the skeletal muscle relaxant class to have language for lack of sedation. Topline results of this clinical trial are expected in early fourth quarter of 2017. The company is planning to commence a Phase 2 study in subjects with painful acute neuromuscular spasms during the first quarter of 2018. Completion of the Phase 2 clinical trial is expected to take approximately one year.
Tolperisone, an approved product that has regulatory approval and is commercialized in many countries outside the United States, has demonstrated in clinical trials improvement in the treatment of skeletal muscle disorders without sedation. The product is currently available in countries outside of the U.S. with an impurity greater than the allowable limit of the FDA. Sanochemia Pharmazeutika AG developed a highly refined form of tolperisone, which provided the basis for patents, including a Composition of Matter patents. The tolperisone patent portfolio extends to 2032 in the United States.
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.
Previously Approved in International Markets
Tolperisone holds a market-leading position in Eastern Europe, Germany and parts of Asia as an approved treatment for muscular pain and neuromuscular spasms. The product has a unique, dual mechanism of action that acts on the peripheral neural system as well as in the spinal cord and brainstem to relieve severe muscular spasms and significantly improve patient mobility. Another major benefit is that clinical studies have shown that tolperisone is efficacious without sedation, which is a common side effect of other marketed skeletal muscle relaxant products.
"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.
"Based on market research and actual patient-use data, physicians and patients have expressed a strong preference for an effective muscle relaxant that has the profile of tolperisone: a rapid onset of action, no risk of abuse, and is non-sedating. In order to confirm the non-sedating properties of tolperisone, Neurana commenced a driving simulation study in the second quarter of 2017. Enrollment has been completed and results are expected by the fourth quarter of this year. In addition, the broad clinical experience and patient usage with this compound outside of the United States suggests a low clinical development and regulatory risk," said Judy Caron, PhD., Neurana's chief operating officer and head of Clinical Development.
Neurana's experienced team has successfully developed, gained regulatory approval for, and commercialized CNS drugs. The team plans to initially develop tolperisone for the treatment of acute, painful muscular spasms and subsequently spasticity for the North American markets (United States, Canada and Mexico).
New Chemical Entity for the US Market
While tolperisone has demonstrated efficacy and safety in years of clinical usage in Germany, Eastern Europe and Asia, it has never been approved in the United States. Tolperisone will represent a novel approach for the treatment of acute, painful muscle spasms and spasticity for US patients utilizing a unique mechanism of action. There is an open investigational new drug application (IND), and data from recent tolperisone pre-clinical and clinical data have been submitted to the FDA. With positive results in the driving simulation study, Neurana plans to initiate Phase 2 clinical trials in the first quarter of 2018.
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.
For Neurana Pharmaceuticals
SOURCE Neurana Pharmaceuticals Inc.