At Belhaven, we accelerate the development of novel dry powder formulations by leveraging the FDA’s 505(b)2 regulatory pathway. This strategic approach allows for the rapid development of formulations that deliver bioequivalent doses of currently approved drugs, shortening the time to approval. The result is short timelines and significantly reduced capital requirements, enabling us to bring innovative treatments to patients more swiftly.
Our commitment to cutting-edge dry powder technology offers a superior alternative to outdated IM autoinjectors. By leveraging our knowledge of dry powder formulations, and utilizing the bioequivalence regulatory pathway, Nasdepi confirms our strategy and ability to accomplish our mission.
We are positioned to move a portfolio of products forward and collaborate with established pharmaceutical partners and government entities. Together, we aim to upgrade the delivery of existing drugs and make them accessible to patients worldwide, revolutionizing the standard of care for emergency medicines.
To determine the pharmacokinetic, pharmacodynamic, and relative bioavailability profiles while assessing safety and tolerability of BBP01 when administered intranasally compared to IM epinephrine in single doses in healthy subjects.
Confirm a dry powder formulation administered intranasally can achieve equivalent or higher epinephrine plasma concentrations in comparison to EpiPen (autoinjector)
Nasdepi® is moving rapidly through clinical development, bringing us closer to a life-saving, needle-free solution for severe allergic reactions. As we progress toward FDA approval and market launch, we invite you to stay informed on our latest milestones.