ExiVex Biopharma (formerly EmerRx Biopharma), a clinical-stage pharmaceutical company developing a proprietary dual-chamber intranasal drug delivery platform, today announced in-human pharmacokinetic (PK) data for its lead candidate EMRX-101, an intranasal naloxone product targeting opioid-induced respiratory depression. In an exploratory PK study in healthy volunteers (n = 13), EMRX-101 (4 mg) delivered approximately 13.7-fold higher cumulative exposure in the first two minutes (AUC0\u20132) and approximately 3.1-fold higher Cmax than the approved comparator. Additionally, EMRX-101 delivered peak plasma naloxone concentration of approximately 14 ng\/mL – approaching IV-like peak plasma concentrations with a Tmax of approximately 6-10 minutes, compared with a Tmax of approximately 25 minutes for a single dose of currently approved 4 mg intranasal naloxone (Narcan\u00ae).<\/p>\n
In the rapidly evolving fentanyl era, opioid overdose reversal increasingly demands intranasal products capable of delivering naloxone faster and at higher early systemic exposure – where the first minutes determine clinical outcomes. ExiVex\u2019s platform was engineered specifically to address this need. The company\u2019s dual-chamber intranasal device, paired with a PK-optimized formulation approach, is designed to overcome the absorption, Tmax, and dose-consistency limitations inherent to first-generation intranasal drug-device combinations. EMRX-101 serves as the first proof-of-value product built on this platform.<\/p>\n
These data reinforce our conviction that the dual-chamber platform can meaningfully improve the speed and magnitude of naloxone delivery in emergency settings, where every minute matters.<\/p>\n
Achieving IV-like peak plasma concentrations through an intranasal device, with a roughly 13-fold increase in early exposure over the first two minutes, represents the kind of step-change the fentanyl era demands. EMRX-101 is the first application of a delivery platform we believe is broadly enabling across acute and emergency-use intranasal therapeutics.\u201d<\/p>\n
Mitch Raponi, Co-Founder and CEO, ExiVex<\/p>\n
ExiVex has obtained FDA agreement on a 505(b)(2) regulatory pathway for EMRX-101 and is advancing IND-enabling activities for the program with the goal of a single registrational PK study to final approval in 2028. Beyond EMRX-101, ExiVex is advancing its intranasal delivery platform across additional acute and emergency rescue indications, with the goal of building a pipeline of differentiated products that share a common underlying device and formulation architecture.<\/p>\n
ExiVex is an Industry Partner of the 4th Nasal Formulation & Delivery Summit, taking place May 19\u201321, 2026 at the Hotel Commonwealth in Boston, MA. Dr. Raponi will deliver a presentation titled \u201cBuilding an Intranasal CNS Drug Delivery Platform: Formulation Strategy, Device Innovation, and EMRX-101 as a Case Study in Emergency-Use Naloxone\u201d on Thursday, May 21, 2026 at 11:45 AM, within the conference\u2019s \u201cTranslating Preclinical Nasal Models to Predict Human Clinical Outcomes\u201d track. The session will detail the platform architecture underlying EMRX-101, the 505(b)(2) regulatory strategy, and the framework\u2019s broader potential across CNS and emergency-use intranasal indications. ExiVex looks forward to discussing the platform, the EMRX-101 dataset, and broader pipeline opportunities with potential partners and collaborators at the meeting.<\/p>\n