Aptar's Bidose System Delivers CARDAMYST™ Nasal Spray Following FDA Approval for PSVT Treatment

Aptar's Bidose System Delivers First Self-Administered PSVT Treatment

Aptar Group, Inc. (ATR) announced that its proprietary Bidose (BDS) Liquid Nasal Spray System is the delivery mechanism for the newly FDA-approved CARDAMYST™ (etripamil) Nasal Spray. The approval, granted to Milestone Pharmaceuticals, marks a significant milestone in cardiovascular medicine, providing the first and only self-administered nasal spray for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.

Key Regulatory Milestone and Market Impact

The FDA’s decision validates the efficacy and safety of etripamil, a novel calcium channel blocker, when delivered through Aptar’s specialized nasal system. PSVT is a condition characterized by episodes of abnormally fast heart rate, and the ability for patients to self-administer treatment outside of a clinical setting represents a major advancement in patient care and quality of life.

“Aptar’s 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 rhyt.”

For Aptar Group, the approval solidifies its position as a leader in drug delivery technologies. The BDS system is designed for precise, reliable dosing, which is critical for a fast-acting cardiovascular medication like etripamil. The successful commercialization of CARDAMYST™ is expected to provide a steady revenue stream for Aptar through the supply of the delivery device.

Milestone's Commercialization Strategy and Forward Guidance

Milestone Pharmaceuticals, the developer of CARDAMYST™, is focused on making the treatment quickly available to PSVT patients in retail pharmacies following the FDA approval. The company anticipates that the drug’s novel delivery method and self-administration capability will drive strong adoption among patients and healthcare providers.

The success of the launch hinges on Milestone’s established launch infrastructure. Furthermore, the company is already looking ahead, with forward-looking statements indicating ongoing development:

• Expectations regarding the timing of CARDAMYST™ availability in retail pharmacies.
• The potential for etripamil as a novel treatment option for PSVT patients.
• Milestone’s ability to successfully execute the commercial launch.
• The timing of patient enrollment in the Phase 3 study of etripamil for AFib-RVR (Atrial Fibrillation with Rapid Ventricular Rate).

The expansion of etripamil into other indications, such as AFib-RVR, suggests a broader therapeutic potential for the drug and, consequently, greater long-term demand for Aptar’s delivery system. The initial market reaction to the PSVT approval is likely to be positive for both companies, reflecting the introduction of a first-in-class, patient-centric treatment option.