ExiVex EMRX-101 Naloxone Shows Fast PK in Humans

ExiVex Biopharma reports EMRX-101 intranasal naloxone achieves near-IV peak levels with faster Tmax than comparator.

ExiVex EMRX-101 Naloxone Shows Fast PK in Humans

Image: news-medical.net

ExiVex Biopharma (formerly EmerRx Biopharma), a clinical-stage company focused on a proprietary dual-chamber intranasal drug delivery platform, announced in-human pharmacokinetic (PK) data for its lead candidate EMRX-101, an intranasal naloxone formulation. The data, presented at a medical conference, indicate that EMRX-101 achieves peak plasma concentrations approaching those of intravenous (IV) naloxone, with a substantially faster time to maximum concentration (Tmax) compared to the currently approved intranasal naloxone comparator.

According to the company's press release dated May 14, 2026, the study involved healthy volunteers and demonstrated that EMRX-101's PK profile could enable more rapid reversal of opioid overdose. The dual-chamber device is designed to deliver a precise dose of naloxone as a fine mist, enhancing absorption through the nasal mucosa.

ExiVex plans to discuss these results with regulatory authorities to determine the next steps toward potential approval. The company emphasizes that faster onset of action is critical in opioid overdose emergencies, where every second counts.

This development comes amid ongoing efforts to address the opioid crisis, with intranasal naloxone products like Narcan already widely used. EMRX-101 aims to improve upon existing options by offering a more rapid pharmacokinetic profile.

❓ Frequently Asked Questions

What is EMRX-101?

EMRX-101 is an intranasal naloxone formulation developed by ExiVex Biopharma, designed for rapid reversal of opioid overdose.

How does EMRX-101 compare to existing naloxone products?

In human PK studies, EMRX-101 showed peak plasma concentrations approaching IV levels and a faster Tmax than the currently approved intranasal comparator.

What is the dual-chamber delivery platform?

It is a proprietary device that delivers a precise dose of naloxone as a fine mist, potentially improving absorption and onset of action.

📰 Source:
news-medical.net →
Share: