What's Happening?
Milestone Pharmaceuticals has received FDA approval for Cardamyst, a calcium channel blocker nasal spray designed to treat paroxysmal supraventricular tachycardia (PSVT), a condition characterized by episodes of rapid heartbeat. This approval marks the
first novel treatment for PSVT in over 30 years. The decision was based on data from the Phase III RAPID study, which demonstrated that 64% of patients using Cardamyst returned to normal heart rhythm within 30 minutes, compared to 31% with a placebo. The drug is expected to be available in the U.S. in early 2026.
Why It's Important?
The approval of Cardamyst is a significant milestone for Milestone Pharmaceuticals, representing a breakthrough in the treatment of PSVT. This development provides a new option for patients who have limited treatment choices for managing their condition. The convenience of a nasal spray offers a practical alternative to intravenous therapies, potentially improving patient compliance and quality of life. For the pharmaceutical industry, this approval highlights the importance of innovation in addressing unmet medical needs and the challenges of navigating the regulatory landscape.
What's Next?
Milestone Pharmaceuticals plans to launch Cardamyst in the U.S. market in the first quarter of 2026. The company is also exploring additional indications for the drug, including atrial fibrillation with rapid ventricular rate, with plans to enter late-stage development. The success of Cardamyst could pave the way for further research and development in similar therapeutic areas. Stakeholders will be monitoring the market reception and patient outcomes closely, which could influence future regulatory and commercial strategies.
