Navigation Links
Neurelis Announces FDA Allowance of IND Application for NRL-1, a Novel Intranasal Diazepam Formulation

SAN DIEGO, Feb. 6, 2012 /PRNewswire/ --  Neurelis, Inc. today announced that the United States Food and Drug Administration (FDA) has cleared an Investigational New Drug application (IND) to commence clinical trials advancing the development of NRL-1 for the treatment of acute breakthrough seizures.   Following initial pre-IND discussions with FDA in late 2011, Neurelis filed the IND based upon the encouraging human pharmacokinetic results seen when comparing absolute bioavailability of NRL-1 relative to intravenous diazepam administration in healthy subjects.  In the IND submission, Neurelis formalized plans for the remaining clinical and non-clinical requirements that FDA agreed to in the pre-IND discussions which will support the submission for marketing approval.

"We are encouraged with our interactions with the FDA and the formalization of our development plan for NRL-1.  The acceptance of the IND is a significant step in advancing the development of this important therapy," stated David F. Hale, Chairman of Neurelis.  "We believe that NRL-1 has demonstrated a pharmacokinetic profile and bioavailability which has not been seen with previous attempts at the intranasal delivery of benzodiazepines.  With the successful development of NRL-1 and approval from the FDA and other regulatory agencies, we look forward to making this product available to those patients who have epilepsy and suffer from acute repetitive seizures."

About NRL-1

NRL-1 (intranasal diazepam) is a proprietary formulation of diazepam delivered via a commercially available nasal sprayer.  It is being developed for the management of patients who require intermittent use of diazepam to control bouts of acute repetitive seizure activity.  There are over 2.7 million people with epilepsy in the United States with approximately 200,000 new patients diagnosed each year.  It is estimated that between 30% to 40% of these patients are uncontrolled on oral therapy and are at-risk for acute breakthrough seizures.  Studies have shown that prolonged or repetitive seizures can cause neurological damage and dramatically increase the risk of changes in neuropsychological function or even death. 

Presently, the only product approved for the treatment of acute repetitive seizures outside of the hospital setting, is a rectally administered formulation of diazepam called Diastat®.  Because of its rectal mode of administration, Diastat® has been primarily relegated to use in younger pediatric patients (usually less than 10 years of age).  The majority of patients with acute repetitive seizures; however, are currently seen in emergency rooms and treated with intravenous benzodiazepines.  Most of these patients are admitted to the hospital.  This represents a significant component of the estimated $15 billion annual economic burden on the system to treat epilepsy in the U.S.  Intranasal diazepam would provide a more convenient alternative to either rectal administration of Diastat® or the need to visit the emergency room for intravenous administration of drugs.

About Neurelis

Neurelis, Inc. is a San Diego-based specialty pharmaceutical company organized to license, develop, and commercialize product candidates for epilepsy and the broader central nervous system ("CNS") market.  Neurelis leverages 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 to address significant unmet medical needs.

Contact: David F. Hale




SOURCE Neurelis, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Particle Sciences Develops Proprietary Nasal Delivery Formulation Used in Neurelis Recently Announced Successful Phase I Pharmacokinetic Study of NRL-01 (intranasal diazepam)
2. Neurelis Announces Positive Results from Phase 1 Pharmacokinetic Study of NRL-01 (intranasal diazepam)
3. Neurelis Announces Completion of Dosing in Study of Intranasal Diazepam
4. Cadence Pharmaceuticals Announces Voluntary Recall of One Lot of OFIRMEV® (Acetaminophen) Injection
5. Genomic Health Announces Formation of New Genetics Subsidiary
6. Aria Diagnostics Announces Name of New Non-Invasive Prenatal Assay - Harmony Prenatal Test™ - and Publication of Study on Specimen Transport
7. Amrita Hospital Information System Announces its First Hospital Meaningful Use Attestation!
8. InspireMD Announces Positive Clinical Data From Trial of MGuard™
9. Adeona Announces Executive Management Transitions and Board of Directors Appointments to Strengthen Companys Synthetic Biologics Strategic Focus
10. Cempra, Inc. Announces Pricing of Its Initial Public Offering of Common Stock
11. Webcast Alert: Heska Announces Fourth Quarter and Year-End 2011 Earnings Conference Call Webcast
Post Your Comments:
(Date:11/25/2015)... Nov. 25, 2015 AAIPharma Services Corp./Cambridge ... of at least $15.8  Million to expand its ... NC . The expansion will provide additional ... the growing demands of the pharmaceutical and biotechnology ... expansion will provide up to 40,000 square feet ...
(Date:11/25/2015)... -- ARKRAY USA , Inc., a leader ... the accuracy of its blood glucose meter systems. Last ... and Cardiovascular Disease in Los Angeles ... 01 meter and the Assure ® Prism ... accurately measure glucose levels in blood is essential for ...
(Date:11/25/2015)... 2015 Kitov Pharma ceuticals ... a biopharmaceutical company focused on the development of therapeutic ... today announced the closing of its previously announced underwritten ... ), each representing 20 ordinary shares of the Company, ... ADSs and warrants were issued in a fixed combination ...
Breaking Medicine Technology:
(Date:11/27/2015)... , ... November 27, 2015 , ... ... largest, most successful and prominent nonprofit healthcare organizations in the country. They have ... with various organizations, and helped advance the healthcare industry as a whole through ...
(Date:11/27/2015)... ... November 27, 2015 , ... Indosoft Inc., developer and ... of Asterisk 11 LTS (Long Term Support) into its Q-Suite 5.10 product line. ... 5.10 up-to-date with a version of Asterisk that will receive not only security ...
(Date:11/26/2015)... ... November 26, 2015 , ... CognisantMD and Cambridge Memorial ... in the Waterloo region. Using the Ocean Platform, family physicians can now order ... electronic medical record (EMR) without the need for redundant patient entry or an ...
(Date:11/26/2015)... ... ... Jobs in hospital medical laboratories and in the imaging field lead the ... Aureus Medical Group . These fields, as well as travel nursing, ranked ... jobs through the company’s website, , The leading healthcare staffing agency ...
(Date:11/26/2015)... Viejo, CA (PRWEB) , ... November 26, 2015 ... ... users a new set of retro-fused, self-animating trailer titles with ProTrailer: Vintage. This ... style options. These classically-influenced trailer titles work with any font, giving users limitless ...
Breaking Medicine News(10 mins):