Belhaven Biopharma is moving forward with the development of Nasdepi, a dry powder nasal epinephrine product, having secured $11 million in an oversubscribed funding round. The funding will support the manufacture of NDA registration lots and facilitate interactions with the FDA to prepare for a pivotal biocomparability study. Simultaneously, Belhaven is initiating a new clinical study to evaluate the commercial dose of Nasdepi for the treatment of severe allergic reactions, with the goal of confirming its safety, efficacy, and bioavailability.
Clinical Study Details
The clinical study is designed to assess Nasdepi's performance under real-world conditions, including a nasal allergen challenge to simulate nasal congestion or irritation. The primary objectives are to determine the extent of epinephrine absorption into the bloodstream following nasal administration compared to intramuscular injection and to confirm the optimal dose for consistent and effective treatment. According to Scott Lyman, CEO of Belhaven Biopharma, this study is a crucial step in confirming Nasdepi's potential as a reliable and easy-to-use solution for anaphylaxis, addressing critical gaps in allergy care.
Addressing Anaphylaxis Treatment Gaps
Anaphylaxis is a severe, potentially life-threatening allergic reaction that requires immediate treatment. Current standard treatments often involve epinephrine autoinjectors, which can present challenges such as needle phobia, temperature sensitivity, and complex administration. Nasdepi aims to overcome these barriers with its needle-free, heat-stable, and easy-to-use dry powder nasal delivery system. The company believes that Nasdepi's innovative delivery system ensures fast absorption, making it a life-saving option in critical situations where time is of the essence.
Belhaven Biopharma's Focus
Belhaven Biopharma specializes in developing life-saving medications delivered quickly and effectively via a simple, dry powder, single-use nasal device. Nasdepi, their lead program, represents a significant advancement in emergency-use epinephrine delivery, potentially expanding global access to this critical medication.
