FAQ: Branded Legacy's FDA Pathway for Intranasal Naloxone Spray
Summary
Branded Legacy's subsidiary BioLegacy Evaluative Group is preparing an FDA Pre-ANDA briefing package for a proprietary intranasal naloxone spray designed to combat the opioid overdose crisis. This development follows their provisional patent filing for an air-driven delivery platform that aims to replicate Narcan's performance while reducing costs and improving global accessibility.
What is the main announcement from Branded Legacy, Inc.?
Branded Legacy 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.
Why is this development significant?
This represents a milestone in addressing the opioid overdose crisis through a cost-effective, scalable solution that aims to improve global accessibility to naloxone treatment.
How does Branded Legacy’s intranasal platform work?
The platform uses an air-driven delivery system designed to replicate Narcan’s performance while significantly reducing costs, with specific dosage options of 2 mg and 4 mg naloxone HCl nasal sprays.
Who is leading this initiative for Branded Legacy?
Kristian Thorlund, Executive Chair of Branded Legacy, is quoted as leading the initiative, stating their platform aims to improve accessibility while reducing costs.
What testing has been conducted on this product?
The submission includes a 60-subject bioequivalence study against Narcan, human factors testing to ensure accessibility for non-medical users, and Chemistry, Manufacturing and Controls specifications.
Where is Branded Legacy’s manufacturing facility located?
The company operates a state-of-the-art GMP manufacturing facility in Vancouver.
Who are Branded Legacy’s strategic collaborators?
The company collaborates with leading institutions including McMaster University and Stanford University to drive transformative research and innovation.
What intellectual property protection does Branded Legacy have?
The company has filed a provisional patent for its air-driven delivery platform, providing intellectual property protection for their innovative technology.
How can I get more information about Branded Legacy?
For more information, visit the company’s website at https://BrandedLegacy.com or view the full press release at https://ibn.fm/UBvl4.
What is the current regulatory status of this product?
The product is in the Pre-ANDA briefing package preparation stage, which is an early step in the FDA approval pathway for generic drug applications.
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