Curated News
By: NewsRamp Editorial Staff
October 22, 2025
Branded Legacy Advances Low-Cost Naloxone Spray to Combat Opioid Crisis
TLDR
- Branded Legacy's intranasal naloxone spray offers a cost-effective alternative to Narcan, potentially capturing market share in opioid overdose treatment.
- BioLegacy's FDA Pre-ANDA package includes bioequivalence studies, human factors testing, and manufacturing specs for 2mg and 4mg naloxone HCl nasal sprays.
- This affordable intranasal naloxone platform improves global accessibility to life-saving overdose reversal medication, addressing a critical public health crisis.
- Branded Legacy's air-driven delivery system uses a provisional patent to deliver naloxone nasally, matching Narcan's performance at lower cost.
Impact - Why it Matters
This development represents a crucial advancement in addressing the ongoing opioid epidemic that has claimed hundreds of thousands of lives globally. The availability of affordable, accessible naloxone could dramatically reduce overdose fatalities by making this life-saving medication more widely distributed to first responders, community organizations, and individuals at risk. Current naloxone products often face cost barriers that limit their deployment in underserved communities most affected by the crisis. A lower-cost alternative could enable broader distribution through public health programs, schools, and community centers, potentially saving countless lives. The timing is particularly significant as opioid-related deaths continue to rise in many regions, making accessible overdose reversal treatments more urgent than ever for public health systems and affected communities.
Summary
Branded Legacy (OTC: BLEG), a forward-thinking holdings company focused on life sciences and wellness innovation, has reached a significant milestone in addressing the opioid crisis. Through its subsidiary BioLegacy Evaluative Group, the company is preparing its FDA Pre-Abbreviated New Drug Application (Pre-ANDA) briefing package for a proprietary intranasal naloxone spray. This development follows BioLegacy's provisional patent filing for an innovative air-driven delivery platform designed to offer a cost-effective, scalable solution to combat opioid overdoses. The submission package includes comprehensive documentation featuring a Target Product Profile for both 2 mg and 4 mg naloxone HCl nasal sprays, detailed Chemistry, Manufacturing and Controls specifications, a robust 60-subject bioequivalence study comparing performance against the market-leading Narcan®, and thorough human factors testing to ensure accessibility for non-medical users.
The company's executive leadership emphasizes that their intranasal platform aims to replicate Narcan's performance while achieving significant cost reductions and improving global accessibility. Branded Legacy leverages strategic collaborations with prestigious institutions including McMaster University and Stanford University, positioning itself as a leader in transformative research and innovation for addiction treatment and harm reduction. With a state-of-the-art GMP manufacturing facility in Vancouver, the company maintains advanced production capabilities to deliver cutting-edge products addressing critical public health challenges. The company's comprehensive approach to product development and regulatory preparation demonstrates their commitment to making life-saving overdose reversal treatments more affordable and widely available, potentially transforming how communities respond to opioid emergencies worldwide.
Source Statement
This curated news summary relied on content disributed by InvestorBrandNetwork (IBN). Read the original source here, Branded Legacy Advances Low-Cost Naloxone Spray to Combat Opioid Crisis
