Milestone® Pharmaceuticals Inc. a biopharmaceutical company focusing on innovative cardiovascular medicines, has announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for etripamil, its primary investigational product aimed at managing paroxysmal supraventricular tachycardia (PSVT).

Joseph Oliveto, the President, and CEO of Milestone Pharmaceuticals, expressed gratitude for the FDA's guidance throughout the resubmission process. He stated their belief in addressing all concerns raised in the Refusal to File letter and their anticipation of collaborating with the FDA during the application review. Oliveto highlighted the potential significance of etripamil nasal spray as a treatment option for PSVT patients upon approval.

The NDA resubmission for etripamil followed FDA guidance obtained in a Type A meeting, held subsequent to receiving a Refusal to File (RTF) letter. The resubmission package included restructured data sets capturing the timing of reported Adverse Events (AEs) and certain reformatted data files to facilitate the FDA's analyses. No additional efficacy or safety data were requested as part of the RTF.

PSVT, a form of arrhythmia or irregular heart rhythm, affects an estimated two million individuals in the United States. It is characterized by sudden onset rapid heartbeats often surpassing 150 to 200 beats per minute, with unpredictable duration lasting several hours. Symptoms include severe palpitations, shortness of breath, chest discomfort, dizziness, or lightheadedness, leading patients to curtail their daily activities. The unpredictability of PSVT episodes and their impact can significantly affect patients' quality of life, particularly those with underlying cardiovascular conditions. Existing treatment options often necessitate visits to the emergency department or invasive procedures.

Atrial fibrillation (AFib), a prevalent arrhythmia marked by irregular and often rapid heartbeats, affects an estimated five million Americans. The subset of patients experiencing atrial fibrillation with rapid ventricular rate (AFib-RVR) seeks acute care due to symptoms such as palpitations, shortness of breath, dizziness, and weakness. While oral medications are available, many patients still require emergency department visits for symptom management. Milestone's research indicates a significant target market for etripamil in AFib-RVR patients.

Etripamil, Milestone's lead investigational product, is a novel calcium channel blocker nasal spray developed for frequent and symptomatic episodes of PSVT and AFib-RVR. Designed for self-administration, it offers rapid response therapy, potentially reducing the need for immediate medical supervision. If approved, etripamil aims to provide healthcare providers with a new treatment option for on-demand care and patient self-management. CARDAMYST™, the proposed brand name for etripamil nasal spray, has undergone extensive clinical trials, including Phase 3 trials for PSVT and Phase 2 trials for AFib-RVR treatment.

 

Source: globenewswire.com

 

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