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Branded Legacy, Inc. (OTC: BLEG) Advances Life-Saving Innovation with FDA Pre-ANDA Briefing for Revolutionary Intranasal Naloxone Spray
Branded Legacy, Inc. (OTC: BLEG) Advances Life-Saving Innovation with FDA Pre-ANDA Briefing for Revolutionary Intranasal Naloxone Spray.
About this update from Branded Legacy Inc.
[{"type":"text","content":"\r\n\r\n \r\n \r\n Branded Legacy, Inc. (OTC: BLEG) Advances Life-Saving Innovation with FDA Pre-ANDA Briefing for Revolutionary Intranasal Naloxone Spray\r\n \r\n \r\n\r\n\r\nBranded Legacy, Inc. (OTC: BLEG) Advances Life-Saving Innovation with FDA Pre-ANDA Briefing for Revolutionary Intranasal Naloxone Spray\r\nPioneering Cost-Effective, Scalable Solutions to Combat the Global Opioid Crisis with Proprietary Air-Driven Delivery Technology\r\n\r\n\r\n\r\n\r\n\r\nVANCOUVER, 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: \r\n 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.\r\n CMC Program: Draft Chemistry, Manufacturing, and Controls specifications aligned with ICH guidelines for both drug substance and proprietary device quality.\r\n PK Study Protocol: A pivotal 60-subject crossover bioequivalence study benchmarked against Narcan®, evaluating pharmacokinetic parameters including Cmax, AUC, and Tmax.\r\n 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.\r\n BioLegacy will seek FDA guidance on: \r\n Confirmation that a single pivotal PK study will satisfy bioequivalence requirements.\r\n Human Factors validation expectations for its custom unitary device.\r\n Specific req...