Aptar Pharma device cleared for use with first intranasal loop diuretic

Aptar Pharma device cleared for use with intranasal loop diuretic: ©Aptar Pharma

Aptar Pharma announced its Unidose Liquid System will serve as the delivery device for Enbumyst, a newly approved nasal spray formulation of the loop diuretic bumetanide.

The U.S. Food and Drug Administration cleared the therapy, developed by Corstasis Therapeutics, as the first intranasal loop diuretic for treating edema associated with congestive heart failure, liver disease, and kidney disorders including nephrotic syndrome in adults.

Enbumyst provides a self-administered alternative to oral and intravenous formulations. Clinical studies showed it produced a faster onset of sodium excretion and absorbed 33% more quickly than oral versions.

Aptar Pharma said the approval demonstrates the potential of nasal drug delivery in systemic therapies. Its Unidose System has already been used in dozens of FDA- and EMA-approved treatments, including for anaphylaxis, epilepsy, migraine and opioid overdose.

“We are pleased to see our Unidose System continually supporting innovative therapies that expand access and convenience for patients,” said Alex Theodorakis, president of Aptar Pharma Prescription. “This approval reflects the growing potential of nasal delivery platforms in systemic treatment.”

Corstasis CEO Ben Esque said the therapy “provides an option we believe has the potential to allow patients to maintain independence in the treatment of their edema.”

Advances in nasal drug delivery

The FDA approval highlights a broader trend in drug development: the growing role of nasal delivery systems as a mainstream alternative for systemic therapies. Once limited largely to allergy sprays and select emergency medications, intranasal technologies are increasingly being designed to handle a wide range of therapeutic needs.

Researchers point to the nasal cavity’s rich vascularization and thin epithelial layer, which allow for rapid absorption directly into the bloodstream. This route can bypass the gastrointestinal tract and first-pass metabolism in the liver, leading to faster onset and more predictable bioavailability than oral medications. For patients, that can translate into shorter time to relief, fewer side effects, and improved convenience.

Single-use nasal devices are also being optimized for ease of administration outside clinical settings. Advances in spray mechanics, particle size engineering, and device ergonomics have reduced dosing errors and improved reliability, making them suitable for both chronic conditions and acute emergencies. For individuals who may struggle with swallowing pills, lack access to infusion centers, or require rapid intervention, nasal sprays are increasingly seen as a practical solution.

Beyond cardiovascular and renal care, nasal delivery is being explored for neurological disorders, metabolic diseases, and hormone therapies. Investigators are particularly interested in the potential for targeting the brain directly via the olfactory and trigeminal pathways, opening doors to new treatment approaches for conditions like Alzheimer’s disease, Parkinson’s, and certain psychiatric illnesses.

While challenges remain—including ensuring consistent dosing across patient populations and scaling production—recent progress has positioned nasal drug delivery as one of the most promising frontiers in patient-centered medicine.