Aptar’s Bidose Nasal System Delivers CARDAMYST™ (etripamil), the First and Only Self-Administered FDA-Approved Nasal Spray for Paroxysmal Supraventricular Tachycardia (PSVT)
Aptar today announced that its Bidose (BDS) Liquid Nasal Spray System is the mechanism for delivering the newly approved CARDAMYST™ (etripamil) Nasal Spray. CARDAMYST received approval by the U.S. Food and Drug Administration (FDA) for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.
This novel treatment was developed by Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines. This marks Aptar’s first combination of dual Bidose delivery systems housed in a consumer-friendly protective two-pack container.
An estimated two million people in the United States are currently diagnosed with PSVT, a type of arrhythmia or abnormal heart rhythm. PSVT is characterized by episodes of sudden onset rapid heartbeats often exceeding 150 to 200 beats per minute, resulting in an estimated 140,000 to 525,000 Emergency Department visits and 40,000 to 120,000 inpatient hospitalizations in the U.S. each year1.
Integrated Bidose Device Container Closure System Ensures Reliable Drug Access CARDAMYST is easy to use and is small enough to be conveniently carried by patients for use as directed. Aptar CSP Technologies collaborated with Milestone Pharmaceuticals to develop a custom-designed, patient-friendly polypropylene container closure system with a fully integrated cap for CARDAMYST. This protective dual-container system is designed to securely house two Bidose delivery mechanisms, with features intended to prevent accidental activation or dropping from the container and help promote reliability at the moment of need.
Gael Touya, President of Aptar Pharma, said, “This approval underscores the broadening of Aptar’s drug delivery solutions for more therapeutic areas and the growing demand for nasal drug delivery. We are pleased that our trusted and proven Bidose nasal system, combined with our protective dual-container system, is now available for patients in yet another therapeutic area.”
Alex Theodorakis, President, Aptar Pharma Prescription, added, “After years of close collaboration with Milestone, this successful outcome proves again our capability to support customers globally to develop and launch complex treatments with easy-to-use and reliable systems.”
“Aptar has been an essential partner in developing and delivering a novel treatment for PSVT that fills a serious unmet need. We are proud to partner with a company that shares our commitment to innovation and quality and look forward to working together to provide CARDAMYST to patients,” said Joseph Oliveto, President and CEO, Milestone Pharmaceuticals.
Proven Nasal Drug Delivery Platforms
Aptar’s Bidose (BDS) and Unidose (UDS) systems are designed for intuitive, reliable intranasal administration and for meeting strict U.S. FDA quality standards. Offering effective and proven single or two-shot intranasal delivery for a variety of medicines, these platforms support pharmaceutical partners in developing emergency use treatments.
Accelerated Development Support via Aptar Pharma Services
This innovative treatment for PSVT is another example of a Combination Product submission, and benefited from Aptar Pharma’s Drug Services offering, a comprehensive portfolio of stage-specific development packages. Aptar’s dedicated Regulatory Affairs experts and analytical scientists help customers proactively address regulatory needs to help expedite approval.
