Neurelis Recieves FDA Fast Track Designation for NRL-1
Neurelis, Inc. today announced that the US Food and Drug Administration (FDA) has designated NRL-1 (intranasal diazepam) as a Fast Track Development program for the management of selected, refractory patients with epilepsy, on a stable regimen of anti-epileptic drugs (AEDs), who require intermittent use of diazepam to control bouts of increased seizures – also referred to as acute repetitive or cluster seizures. Receiving the designation will allow the company to have prioritized interactions with the FDA as Neurelis completes the clinical development program and prepares for submission of a New Drug Application (NDA) for NRL-1 in the United States. In addition, Fast Track Designation affords the potential for a more timely NDA filing and expedited or priority review of the NDA.
NRL-1 is being developed for pediatric, adolescent, and adult epilepsy patients who experience acute repetitive or cluster seizures. The program is in the final stage of clinical development and the NDA application is planned for submission by early 2018.
"We are very excited to have received Fast Track Designation status with the FDA," said Craig C. Chambliss, President and Chief Executive Officer of Neurelis. "We are looking forward to working with the FDA as we complete our clinical development work, assemble our NDA submission, and prepare for the commercialization of NRL-1. We are focused on providing epilepsy patients and health care providers with an effective, well-tolerated, and user-friendly product for the treatment of acute repetitive or cluster seizures."
Jacqueline French, MD, Professor of Neurology at NYU Langone's Comprehensive Epilepsy Center and one of the lead investigators for NRL-1, added, "Presently, there remains an unmet need for epilepsy patients suffering from acute repetitive or cluster seizures. The only approved option currently available requires rectal administration, which can be an issue – especially with adolescent and adult patients. We are studying NRL-1, whose unique formulation should allow us to deliver a therapeutic dose of diazepam via a well-tolerated nasal spray. This would allow for rapid treatment of these seizures where they occur — at home, work, school or elsewhere."
NRL-1 (intranasal diazepam) is a proprietary patented 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.
Acute Repetitive/Cluster Seizures
There are over 2.7 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.
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.