ExiVex Biopharma (formerly EmerRx Biopharma), a clinical-stage pharmaceutical company developing a proprietary dual-chamber intranasal drug delivery platform, today announced human pharmacokinetic (PK) data for lead candidate EMRX-101, an intranasal naloxone product targeting opioid depression. In an exploratory PK study in healthy volunteers (n = 13), EMRX-101 (4 mg) produced an approximately 13.7-fold higher cumulative exposure in the first two minutes (AUC0–2) and about 3.1 times higher Cmax by the approved comparator. Additionally, EMRX-101 produced a peak naloxone plasma concentration of approximately 14 ng/mL—approaching peak plasma concentrations similar to IV with T.max about 6-10 minutes, compared to a Tmax approximately 25 minutes for a single dose of currently approved 4 mg intranasal naloxone (Narcan®).
In the rapidly evolving era of fentanyl, opioid overdose reversal increasingly requires intranasal products capable of delivering naloxone faster and at higher early systemic exposure—where the first few minutes determine clinical outcomes. ExiVex’s platform was designed specifically to address this need. The company’s dual-chamber intranasal device, combined with a PK-optimized formulation approach, is designed to overcome absorption, T.maxand dose consistency limitations inherent in first-generation intranasal drug-device combinations. The EMRX-101 serves as the first proof-of-value product built on this platform.
These data reinforce our belief that the dual-chamber platform can substantially improve the speed and magnitude of naloxone delivery in emergency situations where every minute counts.
Achieving IV-like peak plasma concentrations via an intranasal device, with an approximately 13-fold increase in early exposure during the first two minutes, represents the kind of step change the fentanyl era requires. EMRX-101 is the first application of a delivery platform that we believe broadly enables acute and emergency use intranasal therapy.“
Mitch Raponi, Co-Founder and CEO of ExiVex
ExiVex has received FDA approval of a 505(b)(2) regulatory pathway for EMRX-101 and is advancing IND activation activities for the program with the goal of a single PK study registration through final approval in 2028. Beyond EMRX-101, ExiVex is advancing the contingency platform with additional intranasal goals of building a pipeline of differentiated products that share a common underlying device and formulation architecture.
ExiVex is an industrial partner of 4u Nasal Formulation & Delivery Summit, taking place May 19–21, 2026 at the Hotel Commonwealth in Boston, MA. Dr. Raponi will present a presentation titled “Development of an Intranasal CNS Drug Delivery Platform: Formulation Strategy, Device Innovation, and EMRX-101 as a Case Study in Emergency Naloxone” on Thursday, May 21, 2026 at 11:45 AM, in the conference track “Translating Preclinical Nasal Models to Predict Human Clinical Outcomes.” The session will detail the platform architecture underlying EMRX-101, the 505(b)(2) regulatory strategy, and the framework’s broader potential for CNS and intranasal emergency use indications. ExiVex looks forward to discussing the platform, the EMRX-101 dataset, and broader pipeline opportunities with potential partners and collaborators at the meeting.
Dive into the full agenda for the 4u Nasal Formulation & Delivery Summit here.
