Belhaven's Investigational New Drug (IND) Application Receives FDA Authorization to Proceed
RALEIGH, NORTH CAROLINA / ACCESS Newswire / October 8, 2025 / Belhaven Biopharma, a leader in developing innovative intranasal products for emergency use, today announced that the U.S. Food and Drug Administration ("FDA" or the "Agency") has accepted their IND application for Nasdepi® (BBP01), a novel, investigational nasal powder epinephrine formulation, designed as a needle-free alternative for the emergency treatment of anaphylaxis. This key milestone marks the next step in Nasdepi's development, allowing Belhaven Biopharma to initiate the pivotal biocomparable study designed to demonstrate its pharmacokinetics, pharmacodynamics, and safety, compared to established intramuscular (IM) epinephrine injections and autoinjectors. This follows two clinical trials that were performed under Health Canada and submitted to FDA in the IND.
The trial is a randomized, crossover design to compare Nasdepi 4.5 mg nasal powder against 0.3 mg IM epinephrine manual injection and 0.3 mg epinephrine autoinjector. The study's primary objective is to determine whether Nasdepi achieves comparable epinephrine pharmacokinetic parameters including area under the curve, maximum concentration, and time to peak concentration. Pharmacodynamic measurements will be performed, including blood pressure and heart rate, to confirm the expected physiological response is achieved and in safe and tolerated ranges.
"Millions of people at risk of anaphylaxis still hesitate to carry or have access to epinephrine autoinjectors due to cost, fear, or difficulty of use," said Scott Lyman, CEO of Belhaven Biopharma. "Our goal with Nasdepi is to make epinephrine more accessible and easier to administer in critical moments. This study is a significant step toward delivering a needle-free, heat stable, and reliable treatment option that could transform emergency allergy care and provide a viable treatment where epinephrine is not currently available to patients."
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 epinephrine delivery and expanding global access. Nasdepi, Belhaven's lead program, is the first dry powder nasal device for treating life-threatening allergic reactions. For more information, please visit www.belhavenbio.com.
Forward-Looking Statements
This press release contains "forward-looking statements" based on our management's current beliefs, assumptions, and available information. These statements, which are not historical facts, include expectations regarding financial performance, business plans, clinical and preclinical development, timing and outcomes of trials, regulatory approvals, product potential, competitive position, and market opportunities. Words such as "believe," "may," "will," "anticipate," "intend," and "expect" identify such statements. Forward-looking statements involve risks and uncertainties that may cause actual results to differ materially, including those related to product development, regulatory processes, funding, commercialization, market acceptance, intellectual property, third-party manufacturing, competition, and management retention. These statements reflect current expectations, but given the rapidly changing environment, new risks may emerge and outcomes may differ. We do not undertake any obligation to update forward-looking statements to reflect new information or future events.
Contact Information
Janie Mackenzie
Vice President of Public Relations
janie@ascendantgroupbranding.com
267.969.4992
SOURCE: Belhaven Biopharma
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/belhaven-biopharma-initiates-a-pivotal-biocomparability-study-to-eval-1084221
