Belhaven Biopharma
Belhaven Biopharma is dedicated to developing innovative, accessible, and effective allergy treatments, with a focus on needle-free, dry powder nasal epinephrine solutions like Nasdepi®. Their mission is to make lifesaving allergy medications more accessible, easier to administer, and environmentally sustainable, aiming to improve emergency care worldwide.
Industries
Nr. of Employees
small (1-50)
Products
Dry powder epinephrine nasal spray (unit-dose nasal powder device)
A needle-free, unit-dose dry powder nasal delivery product under clinical development to provide intranasal epinephrine for treatment of severe allergic reactions and anaphylaxis; designed for rapid absorption, passive operation, heat stability, and extended shelf life.
Dry powder epinephrine nasal spray (unit-dose nasal powder device)
A needle-free, unit-dose dry powder nasal delivery product under clinical development to provide intranasal epinephrine for treatment of severe allergic reactions and anaphylaxis; designed for rapid absorption, passive operation, heat stability, and extended shelf life.
Services
Clinical development and regulatory strategy for reformulated products
Early-phase clinical study design and execution combined with regulatory planning focused on bioequivalence pathways to accelerate approvals of reformulated drugs.
Formulation and device development for dry powder nasal products
Development of spray-dried nasal powder formulations and passive unit-dose nasal delivery devices intended for emergency medication administration.
Preclinical and analytical testing for intranasal products
Comparative pharmacokinetic and bioavailability testing in animal models and analytical studies such as nasal deposition assessments and stability evaluations.
Clinical development and regulatory strategy for reformulated products
Early-phase clinical study design and execution combined with regulatory planning focused on bioequivalence pathways to accelerate approvals of reformulated drugs.
Formulation and device development for dry powder nasal products
Development of spray-dried nasal powder formulations and passive unit-dose nasal delivery devices intended for emergency medication administration.
Preclinical and analytical testing for intranasal products
Comparative pharmacokinetic and bioavailability testing in animal models and analytical studies such as nasal deposition assessments and stability evaluations.
Expertise Areas
- Dry powder nasal drug delivery
- Formulation development and spray drying
- Pharmacokinetics and bioavailability studies
- Early-phase clinical trial management
Key Technologies
- Spray-dried powder formulation
- Dry powder intranasal delivery
- Intranasal nasal mucosa absorption
- Pharmacokinetic (PK) and bioavailability testing