Another Needle-Free Emergency Epinephrine Candidate to Begin Clinical Trials

Belhaven Biopharma, a clinical-stage pharmaceutical company, has announced the initiation of a pivotal biocomparability study for its lead product, Nasdepi^® (BBP01). Nasdepi is an investigational, needle-free, dry powder epinephrine designed for the emergency treatment of life-threatening allergic reactions, or anaphylaxis. This critical study is intended to demonstrate that the novel intranasal delivery system is comparable to conventional epinephrine intramuscular (IM) injections and auto-injectors, marking a step toward bringing the treatment option to the global market.

The launch of the trial follows the acceptance of the Investigational New Drug (IND) application by the US Food and Drug Administration (FDA). The study is designed as a randomized, crossover trial that directly compares the pharmacokinetics (PK), pharmacodynamics (PD), and safety profile of the nasal device against standard injection methods. Specifically, the trial is evaluating a 4.5 mg dose of Nasdepi nasal powder against both a 0.3 mg manual IM epinephrine injection and a 0.3 mg epinephrine auto-injector, which is currently the established standard of care.

The primary objective of the study is centered on achieving bio-comparability by analyzing key pharmacokinetic parameters. These include the Area Under the Curve (AUC), Maximum Concentration (Cmax), and the Time to Peak Concentration (Tmax), which together determine the overall drug exposure and speed of absorption into the bloodstream. In addition to PK, the study will measure pharmacodynamic outcomes, such as changes in blood pressure and heart rate, to confirm that Nasdepi achieves the expected and necessary physiological response required to effectively reverse the symptoms of anaphylaxis.

CEO Scott Lyman noted that millions of patients at risk of anaphylaxis often hesitate to carry or use autoinjectors due to factors like high cost, needle phobia, or the difficulty of use under stressful emergency conditions. Nasdepi is specifically engineered to address these barriers by providing an easy-to-use, single-dose nasal device that can be administered painlessly and without concern for patient positioning.

The foundational work supporting the pivotal trial has already revealed several distinct advantages of the dry powder formulation. Previous clinical and nonclinical studies indicated that Nasdepi is rapidly absorbed, reaching clinically relevant epinephrine concentrations faster than IM injections and providing sustained drug exposure. Furthermore, the formulation has demonstrated superior heat stability, retaining over 99% potency even when exposed to high temperatures up to 50°C (122°F), a crucial factor for a life-saving medication that must be carried and stored in diverse environments.

Successful completion of this pivotal biocomparability study will position Nasdepi for a New Drug Application (NDA) submission to the FDA.