Milestone Pharmaceuticals announces plan to resubmit NDA for etripamil for the treatment of paroxysmal supraventricular tachycardia.

Following the previously announced receipt of a Refusal to File letter, Milestone held a Type A Meeting with FDA. FDA indicated that the timing of adverse events (AEs) in question had minimal impact on the overall characterization of the etripamil safety profile. To align with FDA’s guidance, the Company will restructure the data sets that capture timing of reported AEs, reformat certain data files to facilitate FDA’s analyses, and resubmit the NDA. Based on the guidance received during the Type A Meeting, the Company expects that this approach will address the Refusal to File letter from FDA. FDA has not requested that the Company complete additional clinical efficacy or safety trials prior to resubmitting the NDA. The Company expects a standard NDA review period following resubmission of the NDA for etripamil for PSVT, which is planned for 2Q 2024.

"We thank FDA for its thoughtful consideration of our materials and direction on the NDA resubmission," said Joseph Oliveto, President, and Chief Executive Officer of Milestone Pharmaceuticals. "The feedback we continue to receive from key stakeholders, including patients and health care providers, reinforces our belief that etripamil nasal spray has the potential to be a valuable new option for patients with PSVT that may establish a new standard of care, if approved. We are committed to working with FDA to bring this potentially important new treatment to patients and our recent meeting underscores this commitment.”

Considering the revised timeline for NDA submission, the Company has undertaken certain cash conservation measures to reduce spend through program deferrals and team restructuring and expects that the Company’s existing cash resources will fund operations into mid-2025, including the expected Prescription Drug User Fee Act (PDUFA) date for the NDA resubmission. If FDA approval is granted, the Company expects to receive a $75 million payment under an existing royalty agreement, which is intended to fund the potential commercial launch of etripamil for PSVT.