Neurelis Files New Drug Application With The FDA For VALTOCO™ (Diazepam Nasal Spray), An Investigational Treatment For Pediatric, Adolescent And Adult Epilepsy Patients
SAN DIEGO, CA – Sept. 25, 2018 — Neurelis, Inc. today announced that the company has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for VALTOCOTM (diazepam nasal spray) as a treatment for epilepsy patients six years and older who experience increased bouts of seizure activity, also known as […]
Neurelis Expands Worldwide Patent Portfolio with Latest Issuance in Japan
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, […]
Neurelis Completes Series B Financing
Neurelis, Inc. today announced that it has finalized a Series B financing round led by HBM Healthcare Investments. In addition, LYZZ Capital, which led the Series A funding for Neurelis, has participated in the Series B round. The company will utilize the funds to complete clinical trials for NRL-1 (intranasal diazepam), prepare the planned New Drug […]
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 […]
Neurelis Finalizes Series A Financing to Advance Lead Program to NDA Filing
Neurelis, Inc., a specialty pharmaceutical company focused on the treatment of central nervous system disorders, today announced that it has finalized a Series A financing round. The investment, led by LYZZ Capital, is intended to advance the company’s lead program, NRL-1 (intranasal diazepam), through the remaining clinical work in preparation for FDA submission of a […]
Neurelis Initiates Pivotal Clinical Program for NRL-1 in the Treatment of Acute Repetitive Seizures
Following the receipt of Orphan Drug Designation for their lead product, NRL-1 (intranasal diazepam), Neurelis, Inc. (“Neurelis”) today announced the receipt of guidance from the FDA for the final clinical trial requirements necessary for approval of NRL-1. NRL-1 is being developed for pediatric, adolescent, and adult epilepsy patients who experience Acute Repetitive Seizures. Neurelis has […]
Neurelis Receives FDA Orphan Drug Designation for NRL-1 in the Treatment of Acute Repetitive Seizures
Neurelis, Inc. (“Neurelis”) today announced receipt of Orphan Drug Designation from the FDA for their lead program, NRL-1 (intranasal diazepam) for pediatric, adolescent, and adult epilepsy patients who experience acute repetitive seizures. The FDA’s Orphan Drug Designation program provides orphan status to drugs intended for the safe and effective treatment of rare disorders that affect […]