Branded Legacy, Inc. (OTC: BLEG) Advances Life-Saving Innovation with FDA Pre-ANDA Briefing for Revolutionary Intranasal Naloxone Spray
Branded Legacy (OTC: BLEG) said its subsidiary BioLegacy Evaluative Group has begun preparing an FDA Pre-ANDA briefing package for a proprietary air-driven intranasal naloxone spray aimed at treating acute opioid overdose. Key dossier elements include 2 mg and 4 mg naloxone HCl nasal-spray Target Product Profiles with a targeted 18–36 month shelf life, draft CMC work aligned with ICH guidance, a pivotal 60-subject crossover PK bioequivalence study versus Narcan measuring Cmax/AUC/Tmax, and a 20–30 participant device human-factors usability study with a <5% critical-error target.
BioLegacy will request FDA guidance on whether a single pivotal PK study suffices, human-factors validation expectations, and extractables/leachables testing for its custom unitary device. The company cites a provisional patent for the platform and its GMP manufacturing facility to support development and regulatory submissions.
Branded Legacy (OTC: BLEG) ha dichiarato che la sua controllata BioLegacy Evaluative Group ha iniziato a preparare un pacchetto di briefing FDA Pre-ANDA per una spray nasale a base di naloxone guidata dall'aria, proprietaria, mirata a trattare un sovradosaggio acuto di oppioidi. Gli elementi chiave del dossier includono Profili di Prodotto Target per 2 mg e 4 mg di naloxone HCl in spray nasale con una durata di conservazione mirata di 18–36 mesi, un lavoro CMC preliminare allineato alle linee guida ICH, uno studio pivotale PK in crossover su 60 soggetti per bioequivalenza rispetto a Narcan misurando Cmax/AUC/Tmax, e uno studio di usabilità sui fattori umani del dispositivo con 20–30 partecipanti e un obiettivo di <5% errore critico.
BioLegacy richiederà indicazioni FDA su se uno studio PK pivotale unico sia sufficiente, sulle aspettative di validazione dei fattori umani e sui test di estrattibili/leachables per il suo dispositivo unitario personalizzato. L’azienda cita un brevetto provvisorio per la piattaforma e il suo impianto di produzione GMP a supporto dello sviluppo e delle submission regolatorie.
Branded Legacy (OTC: BLEG) dijo que su filial BioLegacy Evaluative Group ha comenzado a preparar un paquete de briefing FDA Pre-ANDA para un aerosol nasal de naloxona dirigido por aire, propietario, destinado a tratar una sobredosis aguda de opioides. Los elementos clave del dossier incluyen perfiles de producto objetivo 2 mg y 4 mg de naloxona HCl en aerosol nasal con una vida útil objetivo de 18–36 meses, un trabajo CMC preliminar alineado con la guía ICH, un estudio pivotal PK de bioequivalencia en cruce con 60 sujetos frente a Narcan midiendo Cmax/AUC/Tmax, y un estudio de usabilidad de factores humanos del dispositivo con 20–30 participantes con un objetivo de <5% de errores críticos.
BioLegacy solicitará orientación a la FDA sobre si basta un único estudio PK pivotal, las expectativas de validación de factores humanos y pruebas de extractables/leachables para su dispositivo unitario personalizado. La compañía cita una patente provisional para la plataforma y su instalación de fabricación GMP para apoyar el desarrollo y las presentaciones regulatorias.
Branded Legacy (OTC: BLEG)가 자회사 BioLegacy Evaluative Group가 대략적으로 FDA Pre-ANDA 브리핑 패키지를 준비하기 시작했다고 밝혔으며, 공기 구동식 코노ナル spray를 이용한 독점적인 비강용 나록손 스프레이가 급성 마약류 과다복용 치료를 목표로 하고 있습니다. 핵심 서류 요소에는 2 mg 및 4 mg 나록손 HCl 비강 스프레이의 Target Product Profiles, 18–36개월의 목표 보관 기간, ICH 가이드에 맞춘 예비 CMC 작업, Narcan 대비 Cmax/AUC/Tmax를 측정하는 60대상 크로스오버 PK 생물학적 동등성 연구, 그리고 20–30 참가자의 디바이스 인적 요소 실사용성 연구와 <5%의 주요 오류 목표를 포함합니다.
BioLegacy는 단일 결정적 PK 연구로 충분한지 여부, 인적 요소 검증 기대치, 자체 단일 디바이스에 대한 추출물/유출물 테스트에 대해 FDA의 지침을 요청할 예정입니다. 본사는 플랫폼에 대한 임시 특허와 개발 및 규제 제출을 지원하기 위한 GMP 제조 시설을 인용합니다.
Branded Legacy (OTC: BLEG) a déclaré que sa filiale BioLegacy Evaluative Group a commencé à préparer un dossier de briefing FDA Pre-ANDA pour un spray nasal naloxone propulsé par air, propriétaire, destiné au traitement du surdosage aigu d’opioïdes. Les éléments clés du dossier incluent des profils de produit ciblé 2 mg et 4 mg de naloxone HCl en spray nasal avec une durée de vie visée de 18–36 mois, des travaux CMC préliminaires alignés sur les directives ICH, une étude pivot PK en crossover sur 60 sujets en bioéquivalence par rapport à Narcan mesurant Cmax/AUC/Tmax, et une étude d’utilisabilité des facteurs humains du dispositif avec 20–30 participants et un objectif d’erreur critique <5%.
BioLegacy demandera des orientations à la FDA sur la suffisance d’une seule étude PK pivot, les attentes de validation des facteurs humains et les tests d’extractables/leachables pour son dispositif unitaire personnalisé. La société cite un brevet provisoire pour la plateforme et son installation de fabrication GMP pour soutenir le développement et les soumissions réglementaires.
Branded Legacy (OTC: BLEG) gab bekannt, dass seine Tochtergesellschaft BioLegacy Evaluative Group damit begonnen hat, einen FDA Pre-ANDA-Briefing-Paket für ein proprietäres luftbetriebenes intranasales Naloxon-Spray zu erstellen, das zur Behandlung einer akuten Opioid-Überdosierung bestimmt ist. Zu den Schlüsseldokumenten gehören 2 mg und 4 mg Naloxon-HCl Nasenspray Zielproduktprofile mit einer vorgesehenen 18–36 Monate Haltbarkeitsdauer, vorbereitende CMC-Arbeiten gemäß ICH-Leitlinien, eine 60-Subject-Crossover-PK-Bioäquivalenzstudie gegenüber Narcan, die Cmax/AUC/Tmax misst, sowie eine 20–30 Teilnehmer umfassende Human-Factors-Usability-Studie des Geräts mit einem <5% Ziel für kritische Fehler.
BioLegacy wird FDA-Richtlinien dazu anfordern, ob eine einzige pivotale PK-Studie ausreicht, welche Erwartungen an die Validierung der Human-Factors bestehen und Tests auf Extraktibles/Leachables für ihr kundenspezifisches Einheitsgerät erforderlich sind. Das Unternehmen verweist auf ein vorläufiges Patent für die Plattform und seine GMP-Herstellungsanlage zur Unterstützung von Entwicklung und regulatorischen Einreichungen.
Branded Legacy (OTC: BLEG) قالت إن شركتها التابعة BioLegacy Evaluative Group بدأت في إعداد حزمة إحاطة FDA Pre-ANDA لراشِة أنفية مقرونة بالهواء تحتوي على نالوكسون مملوكة، وتستهدف معالجة جرعة زائدة حادة من الأفيونيات. تشمل عناصر الملف الأساسية ملفات تعريف المنتج المستهدفة بنسل عام 2 ملغ و4 ملغ من نالوكسون HCl في رذاذ أنفي مع مدة صلاحية مستهدفة تبلغ 18–36 شهراً، وأعمال CMC أولية متوافقة مع إرشادات ICH، ودراسة pivot PK بنسخ متنقلة لـ 60 مشاركاً بخصوص البيوانواية مقارنةً بـ Narcan مع قياس Cmax/AUC/Tmax، ودراسة سهولة استخدام من نوع العوامل البشرية للجهاز مع 20–30 مشاركاً وبهدف <5% من الأخطاء الحاسمة.
سَتُقدِّم BioLegacy طلباً إلى FDA للحصول على توجيهات حول ما إذا كان وجود دراسة PK pivotale واحدة كافياً، وتوقعات مصادقة العوامل البشرية، واختبارات المستخلصات/المذابّات لجهازها الفريد. وتشير الشركة إلى براءة اختراع مؤقتة للمنصة ومرفق تصنيع GMP لدعم التطوير والتقديمات التنظيمية.
Branded Legacy (OTC: BLEG) 宣布其子公司 BioLegacy Evaluative Group 已开始准备一份 FDA Pre-ANDA 简报包，用于一款专有的 气驱动的鼻腔 naloxone 喷雾剂，旨在治疗急性阿片类药物过量。资料要点包括 2 mg 与 4 mg 的鼻喷 naloxone HCl 目标产品特性（Target Product Profiles），拟定保质期为 18–36 个月，与 ICH 指导一致的草拟 CMC 工作，一项用于与 Narcan 对比、测量 Cmax/AUC/Tmax 的 60 例受试者交叉 PK 仪举等效性研究，以及一个 20–30 名参与者 的设备人因学可用性研究，目标关键错误率 <5%。
BioLegacy 将请求 FDA 指导，说明单一的 pivot PK 研究是否足够、对人因验证的期望，以及针对其定制的单一设备的提取物/浸出物测试。公司还提到该平台的临时专利，以及用于支持开发和监管提交的 GMP 制造设施。
- Pre-ANDA package preparation advances regulatory pathway
- Pivotal 60-subject crossover PK study planned versus Narcan
- Target Product Profiles for 2 mg and 4 mg formulations
- GMP manufacturing facility available to support submissions
- Provisional patent filed for air-driven delivery platform
- No FDA approval yet; regulatory outcomes remain pending
- Uncertainty if a single pivotal PK study will satisfy FDA
- Human factors validation requirements remain to be clarified
Pioneering Cost-Effective, Scalable Solutions to Combat the Global Opioid Crisis with Proprietary Air-Driven Delivery Technology
VANCOUVER, 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:
- 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.
- CMC Program: Draft Chemistry, Manufacturing, and Controls specifications aligned with ICH guidelines for both drug substance and proprietary device quality.
- PK Study Protocol: A pivotal 60-subject crossover bioequivalence study benchmarked against Narcan®, evaluating pharmacokinetic parameters including Cmax, AUC, and Tmax.
- 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.
BioLegacy will seek FDA guidance on:
- Confirmation that a single pivotal PK study will satisfy bioequivalence requirements.
- Human Factors validation expectations for its custom unitary device.
- Specific requirements for extractables/leachables testing on medical-grade polymers.
"This milestone reflects our unwavering focus on developing affordable and scalable overdose-reversal therapeutics," said Kristian Thorlund, Executive Chair of Branded Legacy, Inc. "Our intranasal platform aims to replicate Narcan® performance while significantly reducing cost and improving global accessibility—helping save lives in the communities that need it most."
The proprietary air-driven nasal delivery system—previously highlighted in Branded Legacy's September 30, 2025 announcement—represents a cornerstone technology for BioLegacy's expanding drug delivery portfolio. The company continues to leverage its state-of-the-art GMP manufacturing facility, unveiled earlier this year, to accelerate formulation development and support regulatory submissions.
About BioLegacy Evaluative Group, Inc.
BioLegacy Evaluative Group Inc. is a life sciences company dedicated to developing innovative therapies and devices addressing urgent global health challenges. With strategic partnerships at McMaster University and Stanford University, and a newly acquired GMP-compliant manufacturing facility, BLEG is positioned to deliver scalable, cost-effective solutions in areas of high unmet need.
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 www.brandedlegacy.com
Investor Relations:
Branded Legacy, Inc.
Email: info@brandedlegacy.com
Phone: 877-250-9077
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements, including projections regarding market growth, revenue potential, and development timelines, are based on current expectations and beliefs and involve risks and uncertainties that could cause actual results to differ materially. Branded Legacy undertakes no obligation to update these statements except as required by law.
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FAQ
What did Branded Legacy announce on October 22, 2025 regarding its naloxone spray (BLEG)?
What is the planned pivotal bioequivalence study for BLEG's naloxone product?
What formulations and shelf life targets does BLEG aim for in the naloxone spray?
What device usability testing will BioLegacy perform for the BLEG nasal spray?
Will Branded Legacy rely on internal manufacturing for regulatory filings?
What open regulatory questions will BLEG ask the FDA in the Pre-ANDA briefing?
