Milestone Pharmaceuticals' Etripamil Nasal Spray Application Gets FDA's Refusal to File Letter

By Denny Jacob

Milestone Pharmaceuticals received a refusal to file letter from the Food and Drug Administration over its new drug application for its etripamil nasal spray to treat a type of abnormal heart rhythm.

The biopharmaceutical company said the FDA determined that the application for etripamil nasal spray as a treatment of paroxysmal supraventricular tachycardia wasn't sufficiently complete to permit a substantive review based on a preliminary review.

The regulator requested clarification about the time of data recorded for adverse events in Phase 3 clinical trials, said Milestone.

Milestone said the FDA didn't express concerns about the nature or severity of adverse events. It will seek clarification and is planning a meeting with the FDA.

Write to Denny Jacob at denny.jacob@wsj.com

(END) Dow Jones Newswires

December 26, 2023 07:42 ET (12:42 GMT)

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