Milestone Pharma Announces FDA Acceptance of CARDAMYST™ NDA

MONTREAL and CHARLOTTE, N.C., May 29, 2024 – Milestone Pharmaceuticals (Nasdaq: MIST), a company specializing in innovative cardiovascular medicines, announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for CARDAMYST (etripamil) nasal spray on May 26, 2024. This product aims to manage paroxysmal supraventricular tachycardia (PSVT), a condition characterized by sudden, rapid heartbeats. The FDA's Prescription Drug User Fee Act (PDUFA) sets a target date of 10 months from the NDA acceptance for a decision.

Joseph Oliveto, President, and CEO of Milestone Pharmaceuticals, expressed optimism, stating that the FDA’s acceptance brings the company closer to offering a new and effective treatment for PSVT patients. He emphasized the severe impact PSVT has on patients and their families, highlighting the commitment of Milestone's team, patients, and investigators.

The CARDAMYST clinical program is the most extensive data package for an acute drug treatment for PSVT self-management. Milestone is preparing for the commercial launch of etripamil under the trade name CARDAMYST, which has received conditional approval from the FDA.

PSVT affects around two million people in the U.S. It is an arrhythmia that causes sudden, rapid heart rates exceeding 150 to 200 beats per minute, with episodes lasting several hours. Symptoms include severe palpitations, shortness of breath, chest discomfort, dizziness, and anxiety. The unpredictability of these episodes can significantly disrupt daily activities and cause anxiety. PSVT can be particularly harmful to patients with other cardiovascular conditions, often leading to emergency department visits or invasive procedures due to the lack of effective treatments.

CARDAMYST (etripamil) nasal spray represents a novel approach for managing frequent and symptomatic episodes of PSVT and AFib-RVR. Designed for self-administration, it allows patients to manage their condition without immediate medical supervision, providing a sense of control and active management. The clinical trials for CARDAMYST include a completed Phase 3 program for PSVT treatment and a Phase 2 trial for AFib-RVR treatment.

Milestone Pharmaceuticals focuses on developing and commercializing innovative cardiovascular solutions to enhance the lives of individuals with severe heart conditions. The company aims to address unmet patient needs by developing new treatment approaches that allow for patient self-management. CARDAMYST is Milestone's leading investigational product, studied for its potential to treat episodic attacks of PSVT and AFib-RVR.

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