EmerRx Biopharma Receives IRB Approval to Initiate Healthy-Volunteer PK Study of Intranasal Naloxone (EMRX-101)

Randomized crossover study in healthy adults will compare EMRX-101 to the listed 4 mg intranasal naloxone product

Alameda, Calif. – November 27, 2025 – EmerRx Biopharma, LLC today announced Institutional Review Board (Advarra) approval to initiate a healthy-volunteer pharmacokinetic (PK) study of EMRX-101, the company’s improved intranasal naloxone (4 mg). The randomized crossover study will compare EMRX-101 with the listed intranasal naloxone product to characterize early systemic exposure and overall PK.

“IRB approval is a key milestone that enables us to characterize EMRX-101’s early-exposure profile in humans,” said Mitch Raponi, PhD, Co-Founder & CEO of EmerRx. “Our mission is simple – save lives when minutes matter – by delivering intravenous-like speed without a needle.”

About EMRX-101
EMRX-101 is an investigational intranasal naloxone 4 mg formulation delivered via a single-use nasal spray device, designed to optimize early systemic exposure and robust overall exposure with the practicality of intranasal administration. EmerRx intends to pursue a 505(b)(2) NDA as a drug-led combination product.

About EmerRx Biopharma
EmerRx is developing next-generation, needle-free intranasal medicines for time-critical emergencies, starting with EMRX-101 for opioid overdose. EmerRx is headquartered in Alameda, California. Learn more at emerrx.com.

Forward-Looking Statements
Forward-Looking Statements: This release contains forward-looking statements subject to risks and uncertainties. EmerRx undertakes no obligation to update these statements, except as required by law.

Media & Investor Contact
EmerRx Biopharma, LLC
Mitch Raponi, PhD, Co-Founder & CEO