Exivex Reports In-human Pharmacokinetic Data Showing Emrx-101 Intranasal Naloxone Approaches Iv-like Peak Plasma Concentrations With Substantially Faster Tmax Than Currently Approved Comparator

ExiVex Biopharma (formerly EmerRx Biopharma), a clinical-stage pharmaceutical institution processing a proprietary dual-chamber intranasal supplier transportation platform, coming announced in-human pharmacokinetic (PK) information for its lead campaigner EMRX-101, an intranasal naloxone merchandise targeting opioid-induced respiratory depression. In an exploratory PK study successful patient volunteers (n = 13), EMRX-101 (4 mg) delivered astir 13.7-fold higher cumulative vulnerability successful nan first 2 minutes (AUC0–2) and astir 3.1-fold higher Cmax than nan approved comparator. Additionally, EMRX-101 delivered highest plasma naloxone attraction of astir 14 ng/mL - approaching IV-like highest plasma concentrations pinch a Tmax of astir 6-10 minutes, compared pinch a Tmax of astir 25 minutes for a azygous dose of presently approved 4 mg intranasal naloxone (Narcan®).

In nan quickly evolving fentanyl era, opioid overdose reversal progressively demands intranasal products tin of delivering naloxone faster and astatine higher early systemic vulnerability - wherever nan first minutes find objective outcomes. ExiVex’s level was engineered specifically to reside this need. The company’s dual-chamber intranasal device, paired pinch a PK-optimized formulation approach, is designed to flooded nan absorption, Tmax, and dose-consistency limitations inherent to first-generation intranasal drug-device combinations. EMRX-101 serves arsenic nan first proof-of-value merchandise built connected this platform.

These information reenforce our condemnation that nan dual-chamber level tin meaningfully amended nan velocity and magnitude of naloxone transportation successful emergency settings, wherever each infinitesimal matters,

Achieving IV-like highest plasma concentrations done an intranasal device, pinch a astir 13-fold summation successful early vulnerability complete nan first 2 minutes, represents nan benignant of step-change nan fentanyl era demands. EMRX-101 is nan first exertion of a transportation level we judge is broadly enabling crossed acute and emergency-use intranasal therapeutics.”

Mitch Raponi, Co-Founder and CEO, ExiVex

ExiVex has obtained FDA statement connected a 505(b)(2) regulatory pathway for EMRX-101 and is advancing IND-enabling activities for nan programme pinch nan extremity of a azygous registrational PK study to last support successful 2028. Beyond EMRX-101, ExiVex is advancing its intranasal transportation level crossed further acute and emergency rescue indications, pinch nan extremity of building a pipeline of differentiated products that stock a communal underlying instrumentality and formulation architecture.

ExiVex is an Industry Partner of nan 4th Nasal Formulation & Delivery Summit, taking spot May 19–21, 2026 astatine nan Hotel Commonwealth successful Boston, MA. Dr. Raponi will present a position titled “Building an Intranasal CNS Drug Delivery Platform: Formulation Strategy, Device Innovation, and EMRX-101 arsenic a Case Study successful Emergency-Use Naloxone” connected Thursday, May 21, 2026 astatine 11:45 AM, wrong nan conference’s “Translating Preclinical Nasal Models to Predict Human Clinical Outcomes” track. The convention will item nan level architecture underlying EMRX-101, nan 505(b)(2) regulatory strategy, and nan framework’s broader imaginable crossed CNS and emergency-use intranasal indications. ExiVex looks guardant to discussing nan platform, nan EMRX-101 dataset, and broader pipeline opportunities pinch imaginable partners and collaborators astatine nan meeting.

Dive into nan afloat schedule for nan 4th Nasal Formulation & Delivery Summit here.