Aptar Pharma, a global leader in drug delivery and active material science solutions, announced that its Unidose Liquid System (UDS) has been selected as the delivery technology for Enbumyst™ (Bumetanide Nasal Spray) 0.5 mg, recently approved by the U.S. Food and Drug Administration (FDA). Developed by Corstasis Therapeutics, Enbumyst™ is the first intranasal loop diuretic approved for use in adults to treat edema associated with congestive heart failure, liver disease, and kidney disorders, including nephrotic syndrome.
This FDA approval represents not only an important clinical milestone but also the arrival of a new drug-delivery approach for patients living with chronic fluid retention conditions. Until now, patients requiring loop diuretics typically relied on oral or intravenous (IV) therapies, each with limitations in terms of speed, accessibility, and ease of administration.
Enbumyst™: A Novel Intranasal Treatment Option
Enbumyst™ provides a self-administered, outpatient-focused alternative to conventional diuretic treatments. Clinical data supporting approval demonstrated a faster onset of sodium excretion and a 33% increase in absorption speed when compared to oral administration. These findings suggest that the intranasal formulation could be especially beneficial in situations where rapid therapeutic action is necessary or where oral absorption may be compromised.
By harnessing nasal drug delivery, Enbumyst™ addresses two critical needs: patient independence and treatment accessibility. Patients who may struggle with IV therapy in hospital settings or experience poor absorption of oral medications now have access to a convenient, non-invasive, single-use option.
Aptar Pharma’s Unidose System: A Proven Platform
At the heart of this breakthrough is Aptar Pharma’s Unidose Liquid System (UDS), an innovative single-use device designed for systemic absorption through the nasal mucosa. UDS enables patients or caregivers to deliver the entire dose with a simple, intuitive one-step action, removing barriers often associated with more complex delivery methods.
The Unidose System is already recognized globally as the delivery platform behind more than 30 FDA- and EMA-approved therapies, spanning a wide range of conditions from life-threatening emergencies such as opioid overdose and anaphylaxis to chronic neurological diseases such as migraine and epilepsy. With hundreds of millions of units supplied worldwide, Aptar Pharma’s system has become synonymous with safety, reliability, and patient-friendly usability.
Alex Theodorakis, President of Aptar Pharma Prescription, highlighted the broader significance of this latest approval:
“We are pleased to see our Unidose System continually supporting innovative therapies that expand access and convenience for patients. The approval of Enbumyst™ reflects the growing potential of nasal delivery platforms in systemic treatment and underscores Aptar’s mission to enable patient-centric healthcare solutions.”
Corstasis Therapeutics: Focused on Patient Needs
For Corstasis Therapeutics, Enbumyst™ represents an opportunity to reshape patient care in edema management. Ben Esque, Chief Executive Officer of Corstasis, emphasized the alignment between the company’s mission and the innovation made possible through this collaboration:
“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 edema. By enabling self-administration, we are helping patients live more freely while still effectively managing their condition.”
Redefining the Role of Nasal Delivery
Nasal drug delivery has traditionally been associated with local treatments, such as those for allergies, or acute systemic therapies, such as naloxone for opioid overdose. The approval of Enbumyst™, however, highlights a growing recognition of the nasal route as a viable pathway for systemic treatments across therapeutic areas.
By bypassing the gastrointestinal tract, intranasal therapies can avoid issues with variable absorption and first-pass metabolism in the liver. For diuretic therapy in particular, where rapid onset is key to managing symptoms and preventing complications, this delivery method could set a new standard.
Aptar Pharma: Enabling Innovation Across Therapeutic Areas
Aptar Pharma has long been a trusted partner for pharmaceutical companies developing patient-first treatments. Beyond nasal delivery, the company’s portfolio includes pulmonary, dermal, ocular, and injectable solutions, supported by decades of technical expertise and robust manufacturing capabilities. The success of the Unidose System in supporting Enbumyst™ further cements Aptar’s reputation as an enabler of transformative therapies that prioritize safety, usability, and patient quality of life.
Looking ahead, Aptar Pharma anticipates continued growth in the use of nasal delivery platforms for systemic therapies, particularly as pharmaceutical companies seek to expand treatment options that combine effectiveness with convenience and accessibility. The approval of Enbumyst™ demonstrates the potential of this approach to unlock new therapeutic categories, benefiting both patients and healthcare providers.
A Milestone for Patients and Industry
The FDA approval of Enbumyst™ delivered through Aptar Pharma’s Unidose System represents a major milestone for patients with edema linked to heart, liver, or kidney disease. For the biopharmaceutical industry, it underscores the value of partnerships between technology providers and drug developers in accelerating patient-focused innovation.
As more companies explore nasal delivery for systemic treatments, Aptar Pharma’s UDS platform is positioned to remain a cornerstone of reliable, user-friendly, and clinically validated solutions—helping to shape the future of drug delivery worldwide.
About Aptar Pharma
Aptar Pharma is part of AptarGroup, Inc., a global leader in drug and consumer product dosing, dispensing and protection technologies. Aptar serves a number of attractive end markets including pharmaceutical, beauty, food, beverage, personal care and home care. Using market expertise, proprietary design, engineering and science to create innovative solutions for many of the world’s leading brands, Aptar in turn makes a meaningful difference in the lives, looks, health and homes of millions of patients and consumers around the world. Aptar is headquartered in Crystal Lake, Illinois and has more than 13,000 dedicated employees in 20 countries. For more information, visit www.aptar.com.
1 https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.072949
