ExiVex Biopharma has developed a proprietary dual‑chamber intranasal delivery platform that provides drug bioavailability approaching intravenous levels within seconds, eliminating the need for needles. The platform’s first product, EMRX‑101 (naloxone), delivers a rapid, high‑exposure dose for opioid overdose, achieving a 13.7‑fold greater early exposure than standard nasal Narcan® and meeting an FDA‑agreed 505(b)(2) pathway. This technology targets CNS emergencies where IV‑speed drug action is required but expert administration is unavailable.
Funding
Funding not disclosed
Founders
Product
Problem
In acute central nervous system emergencies such as opioid overdose, seizures, severe migraine, or psychiatric crises, rapid drug exposure is critical, yet intravenous administration is rarely available outside clinical settings. Existing intranasal sprays deliver medication too slowly, often requiring multiple doses and failing to achieve the speed needed to prevent irreversible brain injury.
Solution
ExiVex Biopharma’s proprietary dual‑chamber intranasal platform delivers drugs with bioavailability that approaches intravenous levels within seconds, eliminating the need for needles or trained personnel. The system releases a precise dose directly onto the nasal mucosa, achieving a Cmax comparable to an IV reference dose and providing therapeutic exposure up to 13.7‑fold greater in the early phase than standard nasal naloxone. By leveraging an FDA‑agreed 505(b)(2) pathway, the company can register products without a Phase 3 trial, accelerating market entry for emergency‑grade therapies. This approach enables non‑expert responders to administer life‑saving medication within the critical 2‑minute window, improving outcomes in high‑potency opioid overdoses and other CNS emergencies.
Target Audience
Primary customers are emergency medical services, first‑responder organizations, and healthcare providers seeking fast, needle‑free treatment options for opioid overdose, seizures, severe migraine, and acute psychiatric crises.
Features
- Dual‑chamber intranasal device that separates drug and propellant until actuation, ensuring rapid and consistent delivery
- Near‑IV pharmacokinetic profile with Cmax ~14 ng/mL achieved in seconds
- 13.7‑fold higher early exposure compared to conventional nasal naloxone (Narcan®)
- Needle‑free administration usable by laypersons or first responders
- FDA‑agreed 505(b)(2) regulatory pathway allowing registration without a Phase 3 trial
- Platform adaptable to multiple emergency CNS drugs beyond naloxone