VANCOUVER, British Columbia, Oct. 22, 2025 (GLOBE NEWSWIRE) — via IBN — Branded Legacy, Inc. (OTC: BLEG), a dynamic holding company focused on life sciences and wellness innovation, today announced that its subsidiary, BioLegacy Evaluative Group, has commenced preparation of its FDA Pre-Abbreviated New Drug Application (Pre-ANDA) briefing package for the company’s proprietary intranasal naloxone spray—a key step in advancing its regulatory pathway and commercialization strategy.
The upcoming Target Product Profile (TPP) and Pre-ANDA briefing package mark a pivotal advancement following BioLegacy’s previously announced provisional patent filing for its air-driven intranasal platform, designed to address the global opioid overdose crisis with a next-generation delivery system that is cost-effective, stable, and scalable.
The FDA briefing package outlines:
- Target Product Profile (TPP): 2 mg and 4 mg naloxone HCl nasal sprays indicated for acute opioid overdose, with a targeted 18–36-month shelf life.
- CMC Program: Draft Chemistry, Manufacturing, and Controls specifications aligned with ICH guidelines for both drug substance and proprietary device quality.
- PK Study Protocol: A pivotal 60-subject crossover bioequivalence study benchmarked against Narcan®, evaluating pharmacokinetic parameters including Cmax, AUC, and Tmax.
- Device & Human Factors Study: Comparative usability assessment involving 20–30 lay participants with a <5% critical-error target, emphasizing accessibility for non-medical users in emergency scenarios.
BioLegacy will seek FDA guidance on:
- Confirmation that a single pivotal PK study will satisfy bioequivalence requirements.
- Human Factors validation expectations for its custom unitary device.
- Specific requirements for extractables/leachables testing on medical-grade polymers.
“This milestone reflects our unwavering focus on developing affordable and scalable overdose-reversal therapeutics,” said Kristian Thorlund, Executive Chair of Branded Legacy, Inc. “Our intranasal platform aims to replicate Narcan® performance while significantly reducing cost and improving global accessibility—helping save lives in the communities that need it most.”
The proprietary air-driven nasal delivery system—previously highlighted in Branded Legacy’s September 30, 2025 announcement—represents a cornerstone technology for BioLegacy’s expanding drug delivery portfolio. The company continues to leverage its state-of-the-art GMP manufacturing facility, unveiled earlier this year, to accelerate formulation development and support regulatory submissions.
About BioLegacy Evaluative Group, Inc.
BioLegacy Evaluative Group Inc. is a life sciences company dedicated to developing innovative therapies and devices addressing urgent global health challenges. With strategic partnerships at McMaster University and Stanford University, and a newly acquired GMP-compliant manufacturing facility, BLEG is positioned to deliver scalable, cost-effective solutions in areas of high unmet need.
About Branded Legacy, Inc.
Branded Legacy, Inc. (OTC: BLEG) is a forward-thinking holdings company dedicated to pioneering solutions in addiction treatment and harm reduction. Through its subsidiary, BioLegacy Evaluative Group, and strategic collaborations with leading institutions like McMaster University and Stanford University, the company drives transformative research and innovation. With a state-of-the-art GMP manufacturing facility in Vancouver, Branded Legacy leverages advanced production capabilities to deliver cutting-edge products, positioning itself as a leader in addressing critical public health challenges. For more information visit www.brandedlegacy.com
Investor Relations:
Branded Legacy, Inc.
Email: [email protected]
Phone: 877-250-9077
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements, including projections regarding market growth, revenue potential, and development timelines, are based on current expectations and beliefs and involve risks and uncertainties that could cause actual results to differ materially. Branded Legacy undertakes no obligation to update these statements except as required by law.
InvestorWire Service Contact:
IBN
Austin, Texas
www.InvestorBrandNetwork.com
512.354.7000 Office
[email protected]