Milestone Pharma Resubmits Cardamyst NDA

FDA has accepted for review a Milestone Pharmaceuticals NDA resubmission for Cardamyst (etripamil) nasal spray, a self-administered treatment for paroxysmal supraventricular tachycardia (PSVT). The agency has set a user fee review action target date of 12/13.

The resubmission addresses a March FDA complete response letter and includes the submission of new in-vitro data related to nitrosamine impurities and changes in manufacturing oversight. The company noted that the agency has not raised any concerns related to the clinical data in the original NDA.

Milestone says etripamil is a novel calcium channel blocker developed as a nasal spray for on-demand treatment of PSVT and atrial fibrillation with rapid ventricular rate. Designed for patient self-administration, the therapy aims to offer greater autonomy and symptom control for individuals with these unpredictable heart rhythm disorders, according to the company.