MONTREAL and CHARLOTTE, N.C. - Milestone Pharmaceuticals Inc . (NASDAQ:MIST) announced today its intention to resubmit the New Drug Application (NDA) for etripamil, a nasal spray treatment for paroxysmal supraventricular tachycardia (PSVT), to the U.S. Food and Drug Administration (FDA) in the second quarter of 2024.
This decision follows a Type A Meeting with the FDA, which clarified that the timing of adverse events in the application had a minimal impact on the drug's safety profile.
The resubmission will include restructured data sets and reformatted data files to meet FDA requirements, addressing issues from a previous Refusal to File letter without necessitating additional clinical efficacy or safety trials. The company anticipates a standard review period by the FDA following the resubmission.
Joseph Oliveto, President and CEO of Milestone Pharmaceuticals, expressed gratitude towards the FDA for their guidance and emphasized the potential of etripamil to establish a new standard of care for PSVT, pending approval.
The company has implemented cash conservation measures to extend its operating runway into mid-2025, which includes the anticipated Prescription Drug User Fee Act (PDUFA) date for the NDA resubmission.
Etripamil, Milestone's lead investigational product, is a self-administered calcium channel blocker nasal spray designed to provide rapid relief from the acute episodes of PSVT, a condition affecting an estimated two million Americans, characterized by sudden, rapid heartbeats that can cause severe symptoms and impact quality of life.
The potential approval of etripamil could lead to a $75 million payment to Milestone under an existing royalty agreement, intended to support the commercial launch of the product.
Milestone Pharmaceuticals is focused on developing innovative cardiovascular treatments and has emphasized the importance of patient self-management in addressing complex heart conditions. The company's approach to the NDA resubmission aims to bring etripamil, conditionally branded as CARDAMYST™, to patients as a new treatment option for on-demand care.
This article is based on a press release statement from Milestone Pharmaceuticals Inc.
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