Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE

Prism Pharmaceuticals Receives FDA Approval of NEXTERONE

By Pharmaceutical Processing | January 5, 2009

Prism Pharmaceuticals has announced that the FDA has approved the new drug application (NDA) for NEXTERONE(R) (amiodarone HCl) Injection, a novel, patent-protected, cosolvent free formulation of the antiarrhythmic agent Amiodarone IV, originally marketed in the US by Wyeth as Cordarone(R) Intravenous. NEXTERONE is indicated for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. “Approval of our first product is an important corporate milestone and validates our accelerated development model, which allowed us to move NEXTERONE from licensing to FDA clearance in less than three years and ahead of the PDUFA target date,” said Dr. Warren D. Cooper, President and CEO of Prism. “We developed NEXTERONE to overcome solvent-based limitations of conventional intravenous amiodarone and to improve patient care and overall medication management in the setting of life-threatening cardiac arrhythmias.” NEXTERONE represents the first product to successfully overcome the long recognized solubility issues of amiodarone by removing the original cosolvents polysorbate 80 and benzyl alcohol. As a result of removing these cosolvents, NEXTERONE does not have many of the product administration limitations regarding compatibility and stability with plastics and ionic infusion fluids, which are included in the labeling of conventional intravenous amiodarone. Importantly, NEXTERONE does not carry the specific warning about the risk of fatal gasping syndrome in newborn infants because it does not contain benzyl alcohol. Improving medication safety in the hospital environment is an area of significant and current attention. This agenda is being driven by entities such as The Joint Commission, which is responsible for the accreditation of hospitals, and the Institute for Safe Medication Practices. Providing injectable products, especially those for critical care use, in premixed, ready to use forms is a high priority solution to minimize medication errors. Dr. Cooper continued, “While this regulatory approval is for NEXTERONE supplied in vials and a prefilled syringe, the changes in the compatibility and stability profile of NEXTERONE, brought about by the removal of polysorbate 80 and benzyl alcohol, present the opportunity to formulate intravenous amiodarone for the first time in premixed, ready to use configurations.” Prism is currently implementing a full scale manufacturing development program with the Medication Delivery business of Baxter Healthcare Corporation, a world leader in premix technologies. Prism intends to submit supplemental NDA for the premixed configurations which will form the focus of the commercial launch of NEXTERONE as a complete product line. Health-System Pharmacists hold the primary management responsibility for improvements in medication safety in hospitals and this will be a key target customer group for NEXTERONE. “We intend to commercialize NEXTERONE ourselves in the US with partners that are well positioned in the hospital marketplace and will seek to license the ex-US worldwide rights,” said Dr. Cooper. “As we round out the NEXTERONE product line with the premixed bag configurations, we are concurrently defining the best approach to launch the brand, drive rapid conversion and optimize the value of NEXTERONE to pharmacists, clinicians, patients and the Company. I believe NEXTERONE can rapidly replace generic Amiodarone IV when it becomes available and has the potential to eventually render conventional Amiodarone IV obsolete.” The FDA approval of NEXTERONE triggers a second $10M milestone payment from Paul Capital. This long range financing agreement, established in September 2006, provides Prism with non-dilutive capital to enable the company to bring NEXTERONE through the period of NDA review and commercial launch.

Related Articles Read More >

Great Point Partners logo.
Great Point Partners acquires majority stake in Eutecma to fuel sustainable cold chain growth
Driving success in fast-paced high-tech pharma construction projects
This is a photo of the Fujifilm Diosynth Biotechnologies plant under construction in Holly Springs, North Carolina.
Fujifilm, Regeneron ink $3B U.S. manufacturing agreement
This is the logo of Johnson & Johnson.
J&J breaks ground on $2B manufacturing facility in North Carolina
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

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.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 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
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE