Recent research showed that an intranasal epinephrine powder had potential as an important alternative to injections for managing severe allergic reactions, including anaphylaxis, in patients with systemic mastocytosis (SM), according to a news release by Belhaven Biopharma. Belhaven markets an intranasal epinephrine powder as Nasdepi.
A Phase 1 clinical trial reported that the powder was rapidly absorbed and was safe and effective compared to traditional intramuscular epinephrine injections, the company said. The research is slated to be presented at the American College of Allergy, Asthma and Immunology’s 2024 scientific meeting, the company said.
What is SM?
Systemic mastocytosis (SM) is a rare hematological disease characterized by mast cells that are overactive and accumulate in different parts of the body such as the bone marrow, liver, spleen, gastrointestinal tract and lymph nodes.
The trial tested two doses (3.5 mg and 5.5 mg) of its powder and showed a faster onset of action than conventional 0.3 mg and 0.5 mg intramuscular epinephrine. Bloodstream concentrations reached effective levels 48% faster, and peak levels were achieved 22% faster, than with injections, the company reported.
Read more about SM treatment and care
Rapid absorption may be crucial in time-sensitive allergic reactions. The trial found that the powder provided sustained drug exposure, with plasma levels equivalent to or exceeding those seen with intramuscular administration.
The needle-free powder also demonstrated systemic distribution with moderate increases in heart rate and blood pressure, suggesting its effectiveness in delivering epinephrine throughout the body, the company said.
The company added that its dry powder formulation was easy to use, stable under extreme temperatures and unaffected by conditions such as nasal congestion.
The powder was generally well tolerated, with no serious adverse effects reported. Any mild treatment-related symptoms resolved quickly, the company said..
Further research on the powder’s benefits is scheduled to be presented at the Drug Delivery to the Lungs Conference in December.
“We are excited to share our clinical data with the [American College of Allergy, Asthma and Immunology] community,” said Scott Lyman, CEO of Belhaven Biopharma, in a statement. “These results affirm our ability to develop novel life-saving treatment options. Nasdepi represents a breakthrough in epinephrine delivery by offering an easy-to-use, temperature-resistant, and needle-free solution for emergency allergy care.”
