BioMedNewsBreaks — 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/dU7zN

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.

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