Belhaven Biopharma Study Supports Dry Powder Nasal Epinephrine for Dogs

July 9, 2024 — Belhaven Biopharma, a key player in the emergency use of dry powder nasal products, recently unveiled promising outcomes from a nonclinical study. This study, presented at Respiratory Drug Delivery (RDD) 2024, compared the pharmacokinetics of dry powder nasal epinephrine to the conventional autoinjector in a canine model, suggesting a significant advancement for patients with severe allergies prone to anaphylactic reactions.

"In situations where anaphylaxis occurs, quick intervention is critical. Our research reveals that intranasal administration of dry powder epinephrine results in a faster onset of action compared to the FDA-approved autoinjector," stated Scott Lyman, CEO of Belhaven Biopharma. "These results indicate that dry powder nasal epinephrine could offer notable therapeutic benefits, potentially enhancing emergency treatment outcomes for those at risk of severe allergic reactions."

The canine study, in partnership with Lovelace Biomedical, examined an innovative method for administering epinephrine, contrasting it with the intramuscular (IM) administration via an autoinjector. Autoinjectors are the current standard for treating anaphylaxis, which is a potentially fatal allergic reaction. Traditional epinephrine IM injections come with several hurdles, such as needle phobia, slow elevation of epinephrine plasma levels, rapid potency loss when exposed to high temperatures, complex administration procedures, and a short shelf life. Nasdepi®, Belhaven Biopharma's dry powder nasal epinephrine product, aims to address these challenges by offering a needle-free, fast-absorbing, heat-stable, user-friendly, compact, and more cost-effective solution with an extended shelf life.

A pharmacokinetic study was conducted to verify the feasibility of a dry powdered epinephrine formulation delivered via intranasal (IN) administration. This study compared two dose levels of intranasal dry powder epinephrine to an epinephrine autoinjector (EAI) in a canine model. The study was led by Philip J. Kuehl from Lovelace Biomedical and analyzed by William Wargin of Discover PKPD, along with Scott Lyman and Brian Taubenheim from Belhaven Biopharma.

Key Findings:

1. Rapid Effectiveness: Nasal administration of dry powdered epinephrine (IN) reached maximum plasma concentrations within 5 minutes for all subjects tested, significantly quicker than the traditional IM method using an autoinjector, where most subjects attained maximum concentration much later.

2. Increased Drug Exposure: The area under the concentration-time curve (AUC), which indicates total drug exposure over time, was considerably higher for the nasal delivery method. This implies that the nasal route not only delivers epinephrine faster but also maintains an effective concentration for a longer duration compared to traditional autoinjectors.

3. Potential for Better Patient Compliance: The needle-free nasal delivery method could enhance patient compliance, especially for those with needle phobia or difficulty with self-administration.

Study Design & Methods:

The open-label, three-treatment crossover study involved four female beagle dogs and compared two doses of intranasal dry powder epinephrine to the traditional autoinjector. Plasma samples were collected before dosing and at subsequent intervals up to 120 minutes post-dose. Plasma epinephrine concentrations were measured using LC-MS/MS. Key pharmacokinetic parameters such as maximum concentration (Cmax), time to maximum concentration (Tmax), and area under the curve (AUC) were assessed to determine the drug's absorption and maintenance in the bloodstream.

Next Steps:

The encouraging results from this feasibility study prompt further exploration into the efficacy and safety of nasal dry powdered epinephrine for treating anaphylaxis. A pilot clinical study was recently conducted in healthy human subjects, with results aligning with the canine study observations and set to be presented at an upcoming scientific meeting.

Belhaven Biopharma is dedicated to making life-saving allergy medications accessible, effective, and pain-free. Their mission is to revolutionize emergency-use delivery of medications and expand global access with innovative solutions like Nasdepi®.

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