Milestone Misses Approval on Irregular Heart Beat NDA

FDA has issued Milestone Pharmaceuticals a complete response letter on its NDA for Cardamyst (etripamil) nasal spray and its use to convert acute episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. PSVT is described as a sudden, rapid, and irregular heartbeat (arrhythmia) that originates in the upper chambers of the heart (atria).

The agency’s letter requested additional information on nitrosamine impurities based on new draft guidance issued after the NDA submission, adding that a new FDA inspection of the facility that performs release testing for etripamil will be needed to ensure compliance with GMPs because of an ownership change during the NDA review.

Milestone describes etripamil as a novel calcium channel blocker nasal spray. “It is designed as a self-administered rapid response therapy for patients thereby bypassing the need for immediate medical oversight,” it says.