BELHAVEN BIOPHARMA New Canine Study From Belhaven Biopharma Supports Dry Powder Nasal Epinephrine Delivery Solution

Transparency directive : regulatory news

09/07/2024 17:00

Presented at Respiratory Drug Delivery 2024, the Nasdepi Canine Study Indicates the Dry Powder Nasal Solution Provides a Faster and More Effective Treatment for Anaphylaxis as a Result of Severe Allergies

RALEIGH, NC / ACCESSWIRE / July 9, 2024 / Belhaven Biopharma, a leader in emergency use dry powder nasal products, announces the promising results of their latest nonclinical study comparing the pharmacokinetics of dry powder nasal epinephrine to the traditional autoinjector in a canine model. The findings, presented at Respiratory Drug Delivery (RDD) 2024, signify a potential breakthrough treatment for patients with severe allergies at risk of anaphylactic reactions.

"In emergency situations such as anaphylaxis, time is of the essence. Our study demonstrates that intranasal administration of dry powder epinephrine achieves a more rapid onset of action than the FDA-approved autoinjector," said Scott Lyman, CEO of Belhaven Biopharma. "These findings suggest that dry powder nasal epinephrine may offer significant therapeutic advantages, potentially improving emergency treatment outcomes for those at risk of anaphylaxis due to severe allergic reactions."

The canine study, conducted in collaboration with Lovelace Biomedical, explored a new approach to administering epinephrine compared to intramuscular administration (IM) with an autoinjector. Autoinjectors are currently the gold standard for treating anaphylaxis, a potentially life-threatening allergic reaction. Traditional epinephrine IM injections pose several challenges, including needle phobia, slow speed to elevate epinephrine plasma concentrations, rapid loss of potency when exposed to high temperatures, complex administration, and short shelf life. Nasdepi®, a dry powder nasal epinephrine product developed by Belhaven Biopharma, potentially solves these issues by providing a needle-free, rapid-absorbing, heat-stable, easy-to-use, compact, and more affordable solution with a longer shelf life.

To confirm the feasibility of a dry powdered formulation of epinephrine delivered by intranasal (IN) administration, a pharmacokinetic study was performed comparing two dose levels of an intranasal preparation of dry powder epinephrine to an epinephrine autoinjector (EAI) in a canine model. The study was conducted by Philip J. Kuehl (Lovelace Biomedical), and analyzed by William Wargin (Discover PKPD), Scott Lyman, and Brian Taubenheim (Belhaven Biopharma).

Key Findings:

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

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

  • Potential for Better Patient Compliance: The needle-free nasal delivery method could potentially improve patient compliance, especially among those with needle phobia or difficulty with self-administration techniques.

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. Two baseline plasma samples were collected before dosing, and additional samples were taken at 2 or 3, 5, 7, 10, 15, 20, 30, 60, 90, and 120 minutes post-dose. Plasma epinephrine concentrations were measured using LC-MS/MS (range: 200 to 10,000 pg/mL). Key pharmacokinetic parameters such as maximum concentration (Cmax), time to maximum concentration (Tmax), and area under the curve (AUC) were evaluated to assess how quickly and effectively the drug was absorbed and maintained in the bloodstream.

Next Steps

The promising results from this feasibility study warrant further investigation into the efficacy and safety of nasal dry powdered epinephrine for treating anaphylaxis. A pilot clinical study was recently conducted in healthy human subjects. The results correlated with the observations from canine study and will be presented at a future scientific meeting.

Belhaven Biopharma remains committed to creating life-saving allergy medication accessible, effective, and pain-free. To learn more, visit https://belhavenbio.com.

About Belhaven Biopharma

Belhaven Biopharma is a clinical-stage pharmaceutical research company specializing in developing life-saving medications delivered quickly, effectively, and painlessly with a simple, dry powder, single-use nasal device. They are at the forefront of developing nasal dry powder epinephrine, which is revolutionizing emergency-use delivery and expanding global access. Nasdepi® is the first dry powder nasal device for treating life-threatening allergic reactions.

Contact Information

Janie Mackenzie
PR Manager

SOURCE: Belhaven Biopharma


View the original press release on newswire.com.


09/07/2024 17:00
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