Neurelis Announces Two Poster Presentations At The Annual Meeting Of The American Academy Of Neurology
-- Neurelis' lead product candidate for seizures, VALTOCO™ (diazepam nasal spray), currently under FDA review
Apr 29, 2019, 09:00 ET
SAN DIEGO, April 29, 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 two poster presentations at the 71st annual meeting of the American Academy of Neurology being held May 4-10, 2019 in Philadelphia.
The details for the poster presentations are as follows:
Abstract Title: A 12-month, Open-label, Repeat-dose Safety Study of VALTOCO™ (NRL-1, diazepam nasal spray) in Patients with Epilepsy: Interim Report
Date and Time: 11:30 am – 6:30 pm on Sunday, May 5
Authors: Michael Sperling, M.D., Robert Hogan, M.D., Victor Biton, M.D., Dan Tarquinio, M.D., Enrique Carrazana, M.D.for the DIAZ 001.05 Study Group
Topic: Epilepsy/Clinical Neurophysiology (EEG)
Program Number: P1.5-028
Session Name: P1: Epilepsy: Antiseizure Medications
The full abstract can be viewed here.
Abstract Title: Pharmacokinetic Study of VALTOCO™ (NRL-1; diazepam nasal spray) in Patients with Epilepsy Under Ictal and Inter-ictal Conditions – Interim Report
Date and Time: 11:30 am – 6:30 pm on Tuesday, May 7
Authors: Robert Hogan, M.D., Michael Sperling, M.D., Pavel Klein, M.D., Eric Segal, M.D., Enrique Carrazana, M.D. for the DIAZ 001.04 Study Group
Topic: Epilepsy/Clinical Neurophysiology (EEG)
Program Number: P3.5-009
Session Name: P3: Epilepsy: Antiseizure Medications
The full abstract can be viewed here.
The company's lead product, VALTOCO™ (diazepam nasal spray), is a unique formulation of diazepam incorporating the unique combination of a vitamin E–based solution with Intravail®, a proprietary permeation enhancer excipient. VALTOCO has been developed for the management of pediatric, adolescent, and adult patients (age 6 and above) who require intermittent use of diazepam to control bouts of increased seizure activity, also known as cluster or acute repetitive seizures. The science of Intravail® enables the noninvasive delivery of a broad range of protein, peptide, and non-peptide drugs. Intravail® can be utilized via the oral, buccal, dermal, and intranasal drug administration routes. Currently under U.S. Food and Drug Administration (FDA) review, Neurelis is preparing for the commercial launch of VALTOCO.
About VALTOCO™
VALTOCO nasal spray is a proprietary formulation of diazepam, delivered via a nasal spray formulation, developed for the management of pediatric, adolescent, and adult patients who require intermittent use of diazepam to control bouts of increased seizure activity, also known as cluster or acute repetitive seizures. In clinical trials, VALTOCO demonstrated high bioavailability, low variability from dose to dose, and was well tolerated with the most common adverse events being nasal discomfort (seen in 5% of patients in clinical trials). The U.S. Food and Drug Administration (FDA) previously granted Neurelis both Orphan Drug and Fast Track designations for VALTOCO. The New Drug Application (NDA) for VALTOCO is supported by an extensive clinical and pre-clinical package, including studies in healthy volunteers and patients with epilepsy. In the patient studies, more than 2,000 seizures have been treated to date with VALTOCO nasal spray. Currently under FDA review, Neurelis is preparing for the commercial launch of VALTOCO.
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 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 VALTOCO, to address significant unmet medical needs. For more information on the company, please visit www.neurelis.com.
For More Information:
Mark Leonard
[email protected]
847-651-9682
SOURCE Neurelis, Inc.
