FDA chooses not to approve new nasal spray for heart rhythm issues
The U.S. Food and Drug Administration (FDA) has informed Milestone Pharmaceuticals that it is not approving etripamil, the company’s new nasal spray for heart rhythm issues, at this time.
Etripamil is a calcium channel blocker nasal spray developed to treat adult patients with paroxysmal supraventricular tachycardia (PSVT) and atrial fibrillation with rapid ventricular response (AFib RVR). The drug, which industry insiders have been tracking for quite some time, is absorbed into a patient’s bloodstream through the inner lining of the nose within 10 minutes of administration. If approved, it will be marketed and sold in the United States under the brand name Cardamyst.
According to Milestone Pharmaceuticals, the goal with etripamil/Cardamyst is to provide care teams with an on-demand treatment option for these significant complications that patients can administer themselves. The company also believes the drug could decrease the long-term risk of patient complications compared to existing treatment strategies for patients with PSVT and AFib RVR.
The FDA detailed the reasoning behind its decision in a complete response letter (CRL). The company did not object to any of the company’s clinical data or share any specific safety concerns, Milestone Pharmaceuticals emphasized. However, the agency did request more information related on potential nitrosamine impurities and called for an inspection of a facility performing release testing on etripamil.
“We are deeply disappointed by the CRL, but remain committed to the potential of Cardamyst as a novel treatment option that can help patients with PSVT. Our team is evaluating the feedback provided and intends to request a Type A meeting to discuss the issues raised in the CRL,” said Joe Oliveto, president and chief executive officer of Milestone Pharmaceuticals. “We are appreciative of the FDA’s efforts and are confident we can collaborate with the agency with the goal of addressing these issues in a resubmission.”
Click here for additional details from Milestone Pharmaceuticals about etripamil.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.