Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards

Neurelis Regains Rights to Intranasal Diazepam Program

By Pharmaceutical Processing | July 11, 2014

Neurelis, Inc. today announced an agreement with Biotie Therapies Corp. to end the option held by Biotie to purchase Neurelis, clearing the way for Neurelis to commence further development of NRL-1 (intranasal diazepam) for pediatric and adult epilepsy patients who experience acute repetitive seizures.

Over the past year, Biotie has advanced the development program for NRL-1 and worked with Neurelis in preparation for the pivotal clinical work required for NDA submission to the FDA.  Given the need to address other development priorities, Biotie has now decided not to pursue continued development of NRL-1.  Under the terms of the agreement between Biotie and Neurelis, Biotie will have the opportunity to participate in the future success of NRL-1 and recoup the significant investment in the development of the program.

“We are excited at the prospect of advancing the development of NRL-1 to NDA filing, with the goal of bringing this promising and unique therapy to pediatric and adult patients with epilepsy,” stated Craig C. Chambliss, President and Chief Executive Officer of Neurelis.  “The NRL-1 program has progressed significantly over the past year, benefiting from Biotie’s development expertise.  Neurelis is now prepared to complete the development program and the clinical trials requested for submission to the FDA.  Most importantly, we are committed to bringing NRL-1 to the epilepsy community and the patients who may benefit from this novel therapy.”  

Related Articles Read More >

FDA logo
FDA prevented 317 drug shortages in 2021
Pfizer-BioNTech vaccine vial
Pfizer, BioNTech moving forward on seeking COVID-19 vaccine EUA for youngest children
FDA logo
FDA curtails use of Janssen COVID-19 vaccine over blood clotting concerns
FDA logo
FDA sends warning letters to CBD and delta-8 THC product vendors

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Pharmaceutical Processing news in a minute?

We Deliver!
Pharmaceutical Processing Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Pharmaceutical Processing World
  • Subscribe to Our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards