Neurelis, Inc. today announced that the Japan Patent Office (JPO) recently allowed JP Application No. 2014-515967 related to Neurelis’ NRL-1 intranasal diazepam formulation. The patent, when issued, will be in force at least until 2032. NRL-1’s formulation incorporates the unique combination of a Vitamin E-based solvent and Intravail® absorption enhancement with the goal of obtaining unparalleled absorption, tolerability, and reliability in a nasal formulation. NRL-1 is in the final stage of clinical testing for its use in pediatric, adolescent, and adult epilepsy patients who experience acute repetitive or cluster seizures.
With approximately 1 million people affected by the condition, the Japanese epilepsy therapeutic market is expected to continue growing and will reach nearly US$500M by 2026. The company is currently working to assemble its New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) and is planning to file for approval in other countries including Japan.
“We are very excited about the decision of the Japan Patent Office to award this important patent for NRL-1,” said Craig C. Chambliss, President and Chief Executive Officer of Neurelis. “As part of the global patent strategy for our proprietary intranasal formulations, we are pleased to add the Japanese patent to the growing list of issuances in Australia, Canada, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain, Great Britain and the United States.”
The FDA has granted Neurelis received Orphan Drug designation for the NRL-1 in November of 2015 and Fast Track designation in December of 2016. There is a significant unmet clinical need that exists for epilepsy patients suffering from acute repetitive or cluster seizures. The only approved product currently available, Diastat®, requires rectal administration. This route of administration can be an issue – especially with adolescent and adult patients – which limits use. NRL-1 was developed as a unique formulation which allows delivery of a therapeutic dose of diazepam via a well-tolerated nasal spray in order to provide rapid, reliable treatment of these seizures where they occur — at home, work, school or elsewhere.
About NRL-1
NRL-1 (intranasal diazepam) is a proprietary formulation of diazepam, delivered via a nasal formulation in a spray, being developed for the management of pediatric and adult patients who require intermittent use of diazepam to control bouts of acute repetitive seizure activity, also known as cluster seizures. NRL-1 has been granted Orphan Drug and Fast Track Designations by the FDA. In clinical trials, NRL-1 has demonstrated high bioavailability, low variability from dose to dose, and was well-tolerated – with reliable dosing, regardless of when administered.
Acute Repetitive/Cluster Seizures
There are over 3.4 million people with epilepsy in the United States with approximately 200,000 new patients diagnosed each year. It is estimated that between 30% and 40% of these patients are uncontrolled on oral therapy and are at-risk for acute breakthrough seizures. Acute repetitive or cluster seizures may occur over a number of hours or days and can include any seizure type. Studies have shown that prolonged or repetitive seizures can cause neurological damage and dramatically increase the risk of changes in neuropsychological function or even death.
About Neurelis
Neurelis, Inc. is a privately-held San Diego-based specialty pharmaceutical company organized to license, develop, and commercialize product candidates for epilepsy and the broader central nervous system (CNS) market. Neurelis is leveraging its expertise in the development and commercialization of CNS compounds and strong relationships with leading researchers and clinicians in these markets to advance unique product candidates, such as NRL-1 for the treatment of acute repetitive or cluster seizures, to address significant unmet medical needs.