SAN DIEGO, July 26, 2017 — 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 initiation of a simulated comparative driving study to evaluate the non-sedating properties of tolperisone, which is being developed for the relief of neuromuscular spasms. The protocol is being administered by Cognitive Research, a contract research company that has conducted numerous studies using similar protocols. This study is designed as a three-way cross-over study utilizing tolperisone 450mg total dose per day, cyclobenzaprine 30mg total dose per day and placebo. Cyclobenzaprine is the market-share leader in the skeletal muscle relaxant (SMR) market, which represents more than 60 million prescriptions per year.
Neurana anticipates having topline results from the study in late third quarter 2017.
“We are excited to initiate this study and believe that positive results will clearly differentiate tolperisone from other products in the SMR category. Based on market research and actual patient-use data, physicians and patients have expressed a strong preference for an effective product for relief of neuromuscular spasms that has the profile of tolperisone: a rapid onset of action, no risk of abuse, and non-sedating,” said Jeff Raser, Neurana’s president and CEO. “We believe that tolperisone has the potential to provide millions of patients with relief from neuromuscular spasms without sedation, which is a problem with other products in this category.”
“We believe that results of this study, coupled with results from a completed U.S. clinical study that has demonstrated non-sedation of tolperisone, may be sufficient for inclusion in the tolperisone package insert,” said Judy Caron, Ph.D., Neurana’s chief operating officer and head of Clinical Development.
Neurana is the exclusive licensee for tolperisone in North America and other territories from Sanochemia Pharmazeutika AG (ISIN: AT0000776307). The licensing agreement provides Neurana the right to develop and market Sanochemia’s proprietary and patent-protected tolperisone product in the United States and other licensed territories.
Previously Approved in International Markets Tolperisone holds a market-leading position in Germany, Japan, Eastern Europe, Germany and parts of Asia as an approved treatment for muscular pain and neuromuscular spasms. The product has a novel, dual mechanism of action that acts on the peripheral neural system as well as in the spinal cord to relieve severe muscular spasms and significantly improve patient mobility. Another major benefit is that clinical studies have shown that tolperisone has analgesic properties and is efficacious without sedation, which is a common, troubling side effect of other marketed skeletal muscle relaxant products.
Neurana’s experienced team has successfully developed, gained regulatory approval for, and commercialized CNS drugs. The team will initially develop tolperisone for the treatment of acute, painful muscular spasms and subsequently spasticity for the North American markets (United States, Canada and Mexico).
“We are excited to advance the clinical development of tolperisone, which builds on the significant clinical and commercial experience with the drug outside of the United States,” said David F. Hale, Neurana’s executive chairman.
New Chemical Entity for the U.S. Market While tolperisone has demonstrated efficacy and safety in years of clinical practice in Germany, Japan, Eastern Europe and parts of Asia, it has never received regulatory approval from the Food and Drug Administration in the United States. Tolperisone will represent a novel approach for the treatment of acute, painful muscle spasms and spasticity for U.S. patients. Tolperisone is classified as a new chemical entity (NCE) for the U.S. market, which confers regulatory exclusivity. There is an open investigational new drug application (IND), and data from recent tolperisone pre-clinical and clinical trials have been submitted to the FDA. The product is ready to enter Phase 2 clinical studies.
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.
SOURCE Neurana Pharmaceuticals Inc.