Aptar Pharma device powers first intranasal diuretic approved in the US

Aptar Pharma has announced that its Unidose Liquid System is the delivery mechanism for Enbumyst™, the first intranasal loop diuretic to be approved by the US Food and Drug Administration (FDA).

Developed by Corstasis Therapeutics, Enbumyst™ (Bumetanide Nasal Spray) 0.5mg is indicated for the treatment of oedema linked to congestive heart failure, liver and kidney disease, including nephrotic syndrome, in adults.

The therapy provides patients with a convenient, self-administered alternative to conventional oral and intravenous diuretics, supporting outpatient-focused care.

Clinical studies suggest Enbumyst™ delivers a faster onset of sodium excretion and a 33 per cent increase in absorption speed compared with oral administration.

The nasal spray is administered using Aptar Pharma’s single-use Unidose System, which delivers systemic drugs via the nasal mucosa. The platform is already used in more than 30 FDA and European Medicines Agency-approved treatments across a range of conditions, from anaphylaxis and migraine to epilepsy and opioid overdose. It is recognised for its reliability, ease of use and widespread adoption, with hundreds of millions of units supplied globally.

Alex Theodorakis, President of Aptar Pharma Prescription, said: “We are pleased to see our Unidose System continually supporting innovative therapies that expand access and convenience for patients. This approval reflects the growing potential of nasal delivery platforms in systemic treatment and reinforces Aptar’s commitment to enabling patient-centric solutions.”

Ben Esque, Chief Executive of Corstasis Therapeutics, added: “Innovating to address patient needs is central to Corstasis’ mission, and Enbumyst™ provides an option we believe has the potential to allow patients to maintain independence in the treatment of their oedema.”