Study Confirms Nasdepi® Dose Enabling Pivotal Biocomparability Study and Commercial Manufacturing
RALEIGH, NORTH CAROLINA / ACCESS Newswire / April 15, 2025 / Belhaven Biopharma, a leader in innovative treatments for severe allergic reactions, is pleased to share promising results from its dose confirmational clinical trial of Nasdepi®. The study substantiates a dose that is comparable to approved intramuscular injections by evaluating the pharmacokinetic and pharmacodynamic effects in subjects with and without induced allergic rhinitis.
Key Takeaways:
This study validates the commercial dose for FDA registration.
Administration of Nasdepi® after inducting allergic rhinitis with an allergen challenge resulted in more rapid drug exposures and comparable pharmacologic responses compared to subjects without rhinitis symptoms.
Nasdepi was safe and generally well tolerated by subjects with no serious adverse events.
Nasdepi continues to offer the potential as a safe, user-friendly, cost-effective alternative to liquid formulations including autoinjectors, with a longer shelf life and increased global accessibility
The remaining activities required for NDA submission are now underway.
Nasdepi® is a dry powder formulation of epinephrine being developed for intranasal administration to treat Type 1 allergic reactions including anaphylaxis. Nasdepi® remains to have the potential to revolutionize and expand patient access and usability of a life-saving treatment for severe allergic reactions by offering a needle-free alternative that is environmentally robust, user-friendly, and cost-effective. Additionally, Nasdepi® promises to be a more reliable option than approved liquid treatments due to its greatly reduced susceptibility to degradation from prolonged exposure to high temperatures and its invulnerability to freezing. It can also be easily and painlessly administered to conscious or unconscious patients, regardless of their position. These advantages enable a simplified distribution network with the potential for increasing drug availability and breaking down barriers to epinephrine access, resulting in an expanded landscape of emergency anaphylaxis treatment on a global scale.
Scott Lyman, CEO of Belhaven Biopharma, expressed enthusiasm about the results, stating, “The successful outcomes of this dose confirmation and allergic rhinitis study clears the way for our pivotal biocomparibility study to support initial approval in the US. These results further support our objective for Nasdepi® to augment and offer an alternative to approved liquid formulations making this life-saving treatment easier to administer, more accessible, and less intimidating for patients worldwide.”
The study was a 4-way cross-over study in 12 subjects with seasonal allergic rhinitis assessing two different Nasdepi® dose levels and the 0.3 mg EpiPen®. The targeted Nasdepi® dose was studied in subjects with and without induced rhinitis. Both dose levels of Nasdepi® were rapidly absorbed and achieved clinically relevant epinephrine levels in 5 minutes or less. In addition, both doses showed a desirable pharmacodynamic response relevant for the treatment of anaphylaxis which is also the expected biologic response to epinephrine. Peak heart rates and blood pressures were achieved more rapidly with Nasdepi® when compared to the EpiPen® indicating a shortened duration from drug administration to desired physiologic response to reverse anaphylaxis symptoms. There were no severe adverse events (SAEs), and safety findings were generally consistent with known effects of epinephrine and nasal administration.
For more information, please visit belhavenbio.com.
About BBP01-CLN-102
BBP01-CLN-102 is an Open Label, Single Sequence, Dose Confirmation Biocomparability Study to Evaluate the Pharmacokinetics, Absorption, and Pharmacodynamic effects of two different Doses of BBP01 (Epinephrine) Intranasal Powder with and without Nasal Allergen Challenge versus Intramuscular Auto Injector Epinephrine in Subjects with Allergic Rhinitis
About Belhaven Biopharma
Belhaven Biopharma is a pharmaceutical development 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 epinephrine delivery and expanding global access. Nasdepi is Belhaven’s lead program being developed to treat life-threatening allergic reactions.
Contact Information
Janie Mackenzie
Vice President of Public Relations
janie@ascendantgroupbranding.com
267.969.4992
SOURCE: Belhaven Biopharma
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