Neurelis, Inc.

26 articles with Neurelis, Inc.

• 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

  11/23/2020

  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.

• Neurelis Announces National Wholesale And Retailer Chains And Independent Pharmacies Are Now Stocking VALTOCO® (Diazepam Nasal Spray)

  11/9/2020

  Neurelis, Inc., announced today that the company's lead product, VALTOCO® (diazepam nasal spray), is now available through pharmacies nationwide

• Neurelis Announces FDA Approval Of Extended Expiration Dating For VALTOCO® (Diazepam Nasal Spray)

  10/19/2020

  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 activity (ie, s

• Neurelis Announces Four Poster Presentations For The Joint Meeting Of The International Child Neurology Association And Child Neurology Society

  10/16/2020

  - 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 of VALTOCO

• Neurelis Announces Program To Investigate The Safety And Pharmacokinetics Of VALTOCO® (Diazepam Nasal Spray) In Children Aged 2 To 5

  9/23/2020

  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.

• Neurelis Announces Rapid and Broad Payer Coverage of the Company's Flagship Product, VALTOCO® (Diazepam Nasal Spray)

  6/8/2020

  - 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 program for VALTOCO helps commercial patients lower their out-of-pocket costs to as low as $20  

• Neurelis Announces Total Of Nine Poster Presentations For The AANN, AMCP, And AAN Annual Meetings

  5/20/2020

  - 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; Intravail is a key component of VALTOCO formulation   [20-May-2020]

• Neurelis Announces That Intravail® Licensee, ARS Pharmaceuticals' Intranasal Epinephrine Product, Demonstrates Bioequivalent Exposure To Epinephrine Injectors

  5/4/2020

  - 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 - New data further highlight the permeation enhancement potency of Intravail® for both small and large mole

• Neurelis Announces Commercial Availability of VALTOCO® (Diazepam Nasal Spray) for Seizure Cluster Rescue

  3/2/2020

   Neurelis, Inc., announced today the commercial availability of VALTO for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity.

• Neurelis To Present At SVB Leerink 9th Annual Global Healthcare Conference

  2/24/2020

  SAN DIEGO , Feb. 24, 2020 /PRNewswire/ -- Neurelis, Inc., today announced that the company will be participating in the SVB Leerink 9 th 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 Announces FDA Approval for Seizure Rescue Treatment VALTOCO® (Diazepam Nasal Spray) that Incorporates the Science of Intravail® for Consistent and Reliable Absorption

  1/13/2020

  VALTOCO (diazepam nasal spray) is approved by the U.S. Food and Drug Administration (FDA) for use by a care partner outside of the medical setting for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern

• Neurelis Announces Nine Poster Presentations At The Annual Meeting Of The American Epilepsy Society

  12/5/2019

  Neurelis' investigational product candidate, VALTOCO® (diazepam nasal spray), currently under review by the U.S. Food and Drug Administration

• Neurelis Announces Three Poster Presentations At The Annual Meeting Of The Child Neurology Society

  10/22/2019

  Neurelis' investigational product candidate, VALTOCO® (diazepam nasal spray), currently under review by the U.S. Food and Drug Administration

• Neurelis Announces Two Poster Presentations At The Annual Meeting Of The American Academy Of Neurology

  4/29/2019

  Neurelis' lead product candidate for seizures, VALTOCO™ (diazepam nasal spray), currently under FDA review

• Neurelis Announces Completion Of Senior Management Team Buildout To Support The Anticipated Commercial Launch Of VALTOCO™

  4/22/2019

  Neurelis, Inc.,   announced today that the company has completed the buildout of its senior management team to support the anticipated launch of its lead product, VALTOCO™ (diazepam nasal spray).

• Neurelis Announces That Intravail® Licensee ARS Pharmaceuticals Intranasal Epineprhine Program Given Fast Track Designation

  2/20/2019

  ARS Pharmaceuticals announced that ARS-1, an intranasal epinephrine spray in development to treat severe allergic reactions, was granted Fast Track designation by the U.S. Food and Drug Administration

• Neurelis Announces First Product Approved Using The Company's Intravail® Platform

  1/30/2019

  Dr. Reddy's Laboratories and its U.S. subsidiary, Promius Pharma, announced U.S. FDA approval on January 28 for its migraine treatment TOSYMRA™ in the United States

• Neurelis Announces Acquisition Of Aegis Therapeutics, A Leading Drug Delivery Technology Company

  12/3/2018

  Aegis' Intravail® drug delivery technology utilized in Neurelis' VALTOCO™ Nasal Spray, a novel investigational treatment for epilepsy patients   [03-December-2018]   SAN DIEGO , Dec. 3, 2018 /PRNewswire/ -- Neurelis, Inc. today announced the acquisition of Aegis Therapeutics, a San Diego -based drug delivery technology company.  Aegis Therapeutics' proprietary portfol

• Neurelis Files New Drug Application With The FDA For VALTOCO™ Nasal Spray, An Investigational Treatment For Pediatric, Adolescent And Adult Epilepsy Patients

  9/25/2018

  Neurelis, Inc. today announced that the company has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for VALTOCO™.

• Neurelis Expands Worldwide Patent Portfolio With Latest Issuance inn Japan

  11/7/2017

  The patent, when issued, will be in force at least until 2032.