Neurelis Completes Pre-IND Meeting With FDA to Establish Clinical Development Program for NRL-4 in the Treatment of Acute Agitation Associated With Schizophrenia and Bipolar 1 Mania in Adults
SAN DIEGO, CA – November 23, 2020 – Neurelis, Inc., announced today that it has concluded a pre-Investigational New Drug (IND) Application meeting with the U.S. Food and Drug Administration (FDA) regarding NRL-4. The FDA provided direction for the clinical development pathway for the investigational treatment. NRL-4 is being investigated as a noninvasive, easy-to-administer rescue […]
Neurelis Announces National Wholesale and Retailer Chains and Independent Pharmacies Are Now Stocking VALTOCO® (diazepam nasal spray)
SAN DIEGO, CA – November 9, 2020 – Neurelis, Inc., announced today that the company’s lead product, VALTOCO® (diazepam nasal spray), is now available through pharmacies nationwide. VALTOCO was approved by the FDA earlier this year for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that […]
Neurelis Announces FDA Approval of Extended Expiration Dating for VALTOCO® (diazepam nasal spray)
SAN DIEGO, CA – October 19, 2020 – Neurelis, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted extended expiration dating for the company’s lead product, VALTOCO® (diazepam nasal spray). VALTOCO was approved by the FDA on January 10, 2020, for the acute treatment of intermittent, stereotypic episodes of frequent seizure […]
Neurelis Announces Four Poster Presentations for the Joint Meeting of the International Child Neurology Association and Child Neurology Society
— Data continue to support the unique clinical attributes for Neurelis’ lead product, VALTOCO® (diazepam nasal spray), the first and only nasal spray treatment for seizure cluster rescue in pediatric patients 6 years of age and older, adolescents, and adults — Data also highlight that 88 percent of treated seizure episodes used a single dose […]
Neurelis Announces Program to Investigate the Safety and Pharmacokinetics of VALTOCO® (diazepam nasal spray) in Children Aged 2 to 5
SAN DIEGO, CA – September 23, 2020 – Neurelis, Inc., announced today that it will be investigating the safety and pharmacokinetics of the company’s lead product, VALTOCO® (diazepam nasal spray), in children with epilepsy aged two to five. VALTOCO is currently available for adults and pediatric patients 6 years of age and older. This is […]
NEURELIS ANNOUNCES RAPID AND BROAD PAYER COVERAGE OF THE COMPANY’S FLAGSHIP PRODUCT, VALTOCO® (DIAZEPAM NASAL SPRAY)
— More than 176 million lives in the U.S. now covered by payers/managed care/insurance plans within months of FDA approval of VALTOCO, the first and only nasal spray treatment of seizure clusters in patients 6 years of age and older — Neurelis’ patient assistance program supports eligible patients who have no health insurance — Co-pay […]
NEURELIS ANNOUNCES TOTAL OF NINE POSTER PRESENTATIONS FOR THE AANN, AMCP, AND AAN ANNUAL MEETINGS
— Data supports pharmacokinetic and safety profile for Neurelis’ lead product, VALTOCO® (diazepam nasal spray), the first and only nasal spray treatment for seizure cluster rescue in pediatric patients 6 years of age and older, adolescents, and adults — Data also further highlights the permeation enhancer potency of Intravail® for both small and large molecules; […]
NEURELIS ANNOUNCES THAT INTRAVAIL® LICENSEE, ARS PHARMACEUTICALS’ INTRANASAL EPINEPHRINE PRODUCT, DEMONSTRATES BIOEQUIVALENT EXPOSURE TO EPINEPHRINE INJECTORS
— ARS Pharmaceuticals’ lead product, ARS-1 (epinephrine nasal spray) to treat severe allergic reactions, has previously been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) — Neurelis’ lead product, VALTOCO® (diazepam nasal spray), approved by the FDA for seizure cluster rescue, also utilizes Intravail® as a key component of its formulation […]
NEURELIS ANNOUNCES COMMERCIAL AVAILABILITY OF VALTOCO® (DIAZEPAM NASAL SPRAY) FOR SEIZURE CLUSTER RESCUE
— VALTOCO is the first and only nasal spray treatment for seizure cluster rescue in adult and pediatric patients 6 years of age and older — Copay and patient assistance program to be provided by Neurelis for eligible VALTOCO patients SAN DIEGO, CA – March 2, 2020 – Neurelis, Inc., announced today the commercial availability […]
NEURELIS TO PRESENT AT SVB LEERINK 9th ANNUAL GLOBAL HEALTHCARE CONFERENCE
SAN DIEGO, CA – February 24, 2020 – Neurelis, Inc., today announced that the company will be participating in the SVB Leerink 9th Annual Global Healthcare Conference at Lotte New York Palace, New York City. Neurelis President and CEO Craig Chambliss will present at 2:15 pm EST on Tuesday, February 25. About Neurelis Neurelis, Inc. […]