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Milestone Taking Etripamil Into Phase III For AFib Based On Phase II Success

Approval For PSVT Pending At The US FDA

 
• By Mandy Jackson

The company’s calcium channel blocker nasal spray rapidly slowed atrial fibrillation patients’ heart rates, showing potential to be an at-home replacement for emergency room-administered treatment.

Atrial fibrillation medical condition and normal or abnormal heart rate rhythm as a cardiac disorder
Etripamil rapidly slowed ventricular rates in atrial fibrillation patients • Source: Shutterstock

Milestone Pharmaceuticals, Inc.’s inhaled calcium channel blocker etripamil already has shown that it can significantly slow patients’ heart rates in a large Phase III clinical trial as a treatment for paroxysmal supraventricular tachycardia (PSVT). Now, the company plans to initiate a Phase III trial in patients with atrial fibrillation with rapid ventricular rate (AFib-RVR) after the drug was similarly effective at lowering heart rate in the Phase II ReVeRA study of AFib-RVR patients.

Key Takeaways

  • Milestone reported positive Phase II results for its calcium channel blocker etripamil, administered via nasal spray, as a treatment for atrial fibrillation with rapid ventricular rate (AFib-RVR).

  • The drug provided rapid reduction in ventricular rate in the emergency department, with a near 30 beats per minutes difference from placebo within 60 minutes of treatment

Montreal and Charlotte, NC-based Milestone submitted a new drug application for etripamil in the treatment of PSVT to the US Food and Drug Administration in October based on positive results from the 706-patient Phase III RAPID trial

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