BioMedNewsBreaks — Branded Legacy, Inc. (OTC: BLEG) Advances FDA Pathway for Intranasal Naloxone with Pre-ANDA Briefing PreparationOctober 22, 2025 at 13:00 PM EDT
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/UBvl4 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 BioMedWire BioMedWire (“BMW”) is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. 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, BMW 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, BMW brings its clients unparalleled recognition and brand awareness. BMW is where breaking news, insightful content and actionable information converge. To receive SMS alerts from BioMedWire, “Biotech” to 888-902-4192 (U.S. Mobile Phones Only) For more information, please visit https://www.BioMedWire.com Please see full terms of use and disclaimers on the BioMedWire website applicable to all content provided by BMW, wherever published or re-published: https://www.BioMedWire.com/Disclaimer BioMedWire BioMedWire is powered by IBN More NewsView More
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