InvestorWire NewsRoom

InvestorNewsBreak

InvestorNewsBreaks – Branded Legacy, Inc. (OTC: BLEG) Advances FDA Pathway for Intranasal Naloxone with Pre-ANDA Briefing Preparation 
October 22, 2025

InvestorNewsBreaks – Branded Legacy, Inc. (OTC: BLEG) Advances FDA Pathway for Intranasal Naloxone with Pre-ANDA Briefing Preparation 

Branded Legacy (OTC: BLEG), a holding company focused on life sciences and wellness innovation, announced that its subsidiary, BioLegacy Evaluative Group, has begun preparing its FDA Pre-Abbreviated New Drug Application (Pre-ANDA) briefing package for a proprietary intranasal naloxone spray. The milestone follows BioLegacy’s provisional patent filing for its air-driven delivery platform, designed to offer a cost-effective, scalable solution to the opioid overdose crisis. The submission includes a Target Product Profile for 2 mg and 4 mg naloxone HCl nasal sprays, Chemistry, Manufacturing and Controls specifications, a 60-subject bioequivalence study against Narcan(R), and human factors testing to ensure accessibility for non-medical users. “Our intranasal platform aims to replicate Narcan performance while significantly reducing cost and improving global accessibility,” said Kristian Thorlund, Executive Chair of Branded Legacy.

To view the full press release, visit https://ibn.fm/eshvM

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 the company’s website at https://BrandedLegacy.com.

About InvestorWire

InvestorWire (“IW”) is a specialized communications platform with a focus on advanced wire-grade press release syndication for private and public companies and the investment community. It is one of 70+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, IW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, IW brings its clients unparalleled recognition and brand awareness. IW is where breaking news, insightful content and actionable information converge.

For more information, please visit https://www.InvestorWire.com

Please see full terms of use and disclaimers on the InvestorWire website applicable to all content provided by IW, wherever published or re-published: https://www.InvestorWire.com/Disclaimer

InvestorWire
Austin, Texas
www.InvestorWire.com
512.354.7000 Office
[email protected]

InvestorWire is powered by IBN

Recent NewsBreaks

NewsBreaks Categories

Get Started with InvestorWire

To distribute a release in the next 24 hours. Contact our client services team.

(862) 930-1404

Distribute a press release. Submit your release to get started.

Submit Press Release

Set up a Live demonstration. Schedule a date and time that works for you.

Schedule a LIVE Demo

Press Distribution

Explore Press Distribution Solutions

All releases include an unlimited word count* with full wire-grade syndication, our press release enhancement service, and a follow-up InvestorNewsBreak article distributed to thousands of editorial syndication partners.

Discover Add-on Solutions

Increase the impact of your achievements by adding these exclusive solutions from InvestorWire, delivered in conjunction with the InvestorBrandNetwork (IBN).