French specialty pharmaceutical company CROSSJECT announced successful 6-month room temperature stability data for its ZEPIZURE registration batch, marking a significant advancement toward regulatory submission of its needle-free epilepsy emergency treatment.
The registration batch, produced at EUROFINS' qualified manufacturing facility in July 2024, demonstrated satisfactory stability at the 6-month evaluation point. This data complements nine-month stability results previously collected from a batch manufactured in December 2023, strengthening the company's regulatory position.
ZEPIZURE is designed as an emergency treatment for epileptic crises using CROSSJECT's proprietary ZENEO needle-free auto-injector platform. The technology allows for immediate intramuscular injection through clothing, potentially transforming emergency response for seizure management.
Manufacturing Progress Supports Regulatory Timeline
The stability data represents a critical component of the documentation required for the Emergency Use Authorization (EUA) application that the Biomedical Advanced Research and Development Authority (BARDA) plans to file with the U.S. Food and Drug Administration (FDA).
CROSSJECT reports that its contract manufacturing partner EUROFINS is currently producing additional validation batches as part of the comprehensive regulatory application. The company has also completed several successful audits of manufacturing facilities in preparation for potential FDA inspections under the expedited EUA process.
Patrick Alexandre, CEO of CROSSJECT, emphasized the significance of these developments: "We are pleased with this positive manufacturing data which, together with the pending data on validation batches, allows our U.S. partner to complement the electronic dossier of ZEPIZURE. These data also strengthen our relationship with EUROFINS and highlight the hard work and dedication of both teams over the last months."
Dual-Purpose Application for Public Health and National Security
The manufacturing progress supports CROSSJECT's $60 million contract with BARDA, which aims to enhance U.S. national preparedness against chemical threats while addressing critical medical needs.
"This data is a critical step that further builds on our manufacturing know-how and the versatility of the ZENEO platform," Alexandre added. "If approved, the planned procurement of ZEPIZURE could increase U.S. national preparedness against chemical threats while broadening the availability of the ZENEO needle-free auto-injectors."
Expanding the ZENEO Platform
CROSSJECT's ZENEO technology platform represents a significant innovation in emergency medicine delivery. The needle-free system is designed to enable patients or untrained caregivers to administer emergency medications via intramuscular injection instantly, even through clothing.
Beyond ZEPIZURE, CROSSJECT is developing additional emergency applications for the ZENEO platform, including treatments for allergic reactions, adrenal insufficiencies, and other emergency indications.
The successful stability data for ZEPIZURE not only advances this specific product toward potential approval but also validates the broader ZENEO platform's capabilities for future emergency medicine applications.
Regulatory Pathway
The stability data will support both the immediate EUA application and the subsequent New Drug Application (NDA) for full market approval of ZEPIZURE in the United States. The EUA pathway could potentially accelerate ZEPIZURE's availability for emergency use while the standard approval process continues.
CROSSJECT's progress with ZEPIZURE represents a significant step forward in addressing the unmet need for rapid, easy-to-administer emergency treatments for epileptic seizures, particularly in non-medical settings where immediate intervention can be critical.
