The U.S. Food and Drug Administration (FDA) has decided not to approve etripamil, a nasal spray developed by Milestone Pharmaceuticals for treating heart rhythm issues, at this time. Etripamil, a calcium channel blocker, is intended to treat patients with paroxysmal supraventricular tachycardia (PSVT) and atrial fibrillation with rapid ventricular response (AFib RVR). If approved, it would be marketed in the U.S. as Cardamyst.
Milestone Pharmaceuticals stated that the nasal spray, which is absorbed through the nose within 10 minutes, would offer patients an on-demand treatment option that could reduce the long-term risks associated with current treatments for these conditions. While the FDA’s complete response letter (CRL) did not raise concerns about the clinical data or safety of etripamil, the agency requested additional information regarding potential nitrosamine impurities and an inspection of the facility handling the release testing.
“We are deeply disappointed by the CRL,” said Joe Oliveto, CEO of Milestone Pharmaceuticals. “However, we remain committed to the potential of Cardamyst and intend to work with the FDA to address the issues raised for resubmission.”
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