MONTREAL and CHARLOTTE, N.C. – Milestone Pharmaceuticals Inc . (NASDAQ:MIST), a company specializing in cardiovascular treatments, has announced that the U.S. Food and Drug Administration (FDA) has accepted their New Drug Application (NDA) for CARDAMYST (etripamil) nasal spray. The FDA set a Prescription Drug User Fee Act (PDUFA) target date 10 months from the acceptance date, which was May 26, 2024.
CARDAMYST, Milestone's lead investigational product, is designed for the management of paroxysmal supraventricular tachycardia (PSVT), a condition affecting an estimated two million Americans. PSVT causes sudden episodes of rapid heartbeats, which can lead to symptoms such as severe palpitations, shortness of breath, and chest discomfort, impacting patients' quality of life.
The clinical trial program for CARDAMYST is reported to be the largest ever conducted for an acute drug treatment for PSVT intended for patient self-management. Joseph Oliveto, President and CEO of Milestone Pharmaceuticals, emphasized the potential of CARDAMYST to provide a new and convenient treatment option for patients, highlighting the collaborative effort of the Milestone team, patients, and investigators.
CARDAMYST is a novel calcium channel blocker nasal spray under clinical development not only for PSVT but also for atrial fibrillation with rapid ventricular rate (AFib-RVR). If approved, it aims to enable patients to administer the treatment themselves without immediate medical oversight, potentially offering a greater sense of control over their condition.
Milestone Pharmaceuticals, with a focus on addressing unmet patient needs in cardiovascular care, continues to prepare for the anticipated commercial launch of etripamil, which has a conditionally approved trade name, CARDAMYST.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.