Belhaven Biopharma, Inc, a clinical-stage pharmaceutical company based in Raleigh, North Carolina, has announced the start of a pivotal clinical trial evaluating BBP01 (trademarked under the name Nasdepi®), an experimental nasal powder formulation of epinephrine. The treatment is being developed as a needle-free alternative to traditional epinephrine injections for people experiencing anaphylaxis, a potentially life-threatening allergic reaction.
The study will compare BBP01 with two established methods of administering epinephrine: a 0.3mg epinephrine auto-injector and a 0.3mg manual intramuscular injection of Adrenalin®, a brand of epinephrine injection. Participants will receive all three treatments in a randomized sequence, allowing researchers to compare how quickly and effectively each method delivers epinephrine into the bloodstream and how the body responds.
The trial will enroll 60 healthy adults and focus primarily on bioavailability, which measures how much of a drug reaches the bloodstream and how quickly it gets there. Researchers hope to determine whether BBP01 can deliver epinephrine at levels and speeds comparable to traditional injections, an important step toward establishing its suitability for treating anaphylaxis. Because the study involves healthy volunteers rather than patients experiencing allergic emergencies, it will not directly measure how effectively BBP01 treats anaphylaxis.
In addition to measuring epinephrine absorption, researchers will evaluate the treatment’s safety, tolerability, and effects on the body. These assessments will include examinations of the nasal passages and measurements of changes in blood pressure, heart rate, and mean arterial pressure, an indicator of average blood pressure throughout a heartbeat.
Company leadership emphasized the importance of the trial in advancing BBP01 toward potential FDA approval. “This study will generate the definitive data we need to conduct our pre-NDA meeting with FDA in 1Q27,” said Scott Lyman, Chief Executive Officer of Belhaven Biopharma. The meeting, planned for the first quarter of 2027, would allow the company to discuss its findings with the FDA before submitting an application for approval.
Lyman also pointed to previous discussions with federal regulators as evidence of the company’s progress. “Confirming FDA alignment with our previous interactions on the work completed in the clinic, human factors, and manufacturing validates that we move into completing the remaining supportive work needed for filing our NDA in 2027,” he added. Although Belhaven reports progress in its discussions with the FDA, additional studies and supporting work must be completed before the company can submit its planned New Drug Application later in 2027.
Belhaven specializes in dry-powder medications delivered through single-use, needle-free nasal devices. Its lead product, marketed under the name Nasdepi®, is described by the company as the first dry-powder nasal device developed to treat life-threatening allergic reactions. Unlike currently FDA-approved epinephrine treatments, BBP01 remains investigational, and its safety and effectiveness for treating anaphylaxis have not yet been established.
