Neurelis’ investigational product candidate, VALTOCO® (diazepam nasal spray), currently under review by the U.S. Food and Drug Administration
| SAN DIEGO, Oct. 22, 2019 /PRNewswire/ -- Neurelis, Inc., a privately held specialty pharmaceutical company focused on licensing, developing and commercializing product candidates for epilepsy and the broader central nervous system (CNS) market, announced today that the company will have three poster presentations at the 48th annual meeting of the Child Neurology Society being held October 23-26 in Charlotte, North Carolina.
The details for the poster presentations are as follows: Abstract title: Digital and Technological Opportunities in Epilepsy: A Future Self-Management Ecosystem Date and time: 4:00-5:30 p.m. on Thursday, October 24 Authors: John D. Hixson, M.D.; Ross Shegog, Ph.D.; Nancy Santilli, NP, MN; Lana Braverman, Pharm.D. The full abstract (No. 49) can be viewed at https://www.childneurologysociety.org/docs/default-source/2019-CNS/2019-cns-program.pdf?sfvrsn=2 Abstract title: Safety of Valtoco® (NRL-1; Diazepam Nasal Spray) in Children and Adolescents with Epilepsy: Interim Subgroup Results from a Phase 3, Open-Label, 12-Month Repeat Dose Study Date and time: 7:00-8:15 a.m. on Friday, October 25 Authors: Eric Segal, M.D.; Daniel Tarquinio, D.O.; Ian Miller, M.D.; Dennis Dlugos, M.D.; James W. Wheless, M.D.; Enrique Carrazana, M.D.; and Adrian L. Rabinowicz, M.D. for the DIAZ 001.04 Study Group The full abstract (No. 60) can be viewed at https://www.childneurologysociety.org/docs/default-source/2019-CNS/2019-cns-program.pdf?sfvrsn=2 Abstract title: Pharmacokinetics and Safety of Valtoco® (NRL-1; Diazepam Nasal Spray) in Children with Epilepsy During Seizure (Ictal/peri-ictal) and Non-Seizure (Inter-ictal) Conditions: Results from a Phase 1, Open-Label Study Date and time: 7:00-8:15 a.m. on Friday, October 25 Authors: Daniel Tarquinio, D.O.; Eric Segal, M.D.; James W. Wheless, M.D.; Adrian L. Rabinowicz, M.D.; and Enrique Carrazana, M.D., for the DIAZ 001.04 Study Group The full abstract (No. 64) can be viewed at https://www.childneurologysociety.org/docs/default-source/2019-CNS/2019-cns-program.pdf?sfvrsn=2 About VALTOCO The company’s investigational product candidate, VALTOCO (diazepam nasal spray), is currently under review by the U.S. Food and Drug Administration as a treatment for intermittent use in adults and children 6 years and older with epilepsy, on stable regiments of antiepileptic drugs (AEDs), to control bouts of increased seizure activity, often referred to as cluster or acute repetitive seizures (ARS). VALTOCO is a proprietary formulation of diazepam, incorporating the unique combination of a vitamin E–based solution and Intravail® transmucosal absorption enhancement technology. Despite the availability of chronic, daily oral medications to control epilepsy, it is estimated that 170,000 individuals in the United States are at risk for cluster or acute repetitive seizures. In a long-term, open-label clinical trial, the safety of VALTOCO was evaluated: 190 patients were enrolled and 2,274 seizures were treated. Approximately 92% of the seizures treated with a single dose of VALTOCO did not require a second dose within at least 24 hours. The most common adverse event in clinical trials was nasal discomfort (seen in 5% of patients). About Neurelis Neurelis, Inc., is an innovation-driven neuroscience company providing a highly differentiated approach to target unmet medical needs. Neurelis is focused on the development and commercialization of product candidates for epilepsy and the broader central nervous system (CNS) market. In addition to VALTOCO, the company is developing NRL-2 for intermittent use to control acute anxiety episodes or panic attacks, and NRL-3 as a noninvasive acute therapy to stop seizures that have progressed to status epilepticus. The Neurelis technology platform includes Intravail®, ProTek® and Hydrogel™, three proprietary noninvasive drug-delivery and stabilization technologies applicable to a wide range of molecules, including therapeutic proteins, peptides, non-peptide macromolecules and small molecules. For more information on Neurelis, please visit www.neurelis.com. For More Information:
SOURCE Neurelis, Inc. |
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