Milestone to Present Phase 3 CARDAMYST Data Showing 1.8 mmHg BP Change and 0.4% Hypotension
Milestone’s Phase 3 analysis of CARDAMYST nasal spray in 1,610 PSVT patients showed mean systolic BP changes of 1.8 mmHg for 70 mg dose (N=440) and 0.0 mmHg for repeat dosing (N=714). Hypotension and syncope rates were 0.4% and 0.2% in the study, respectively, with all adverse events resolving without medical intervention.
1. Phase 3 Trial Safety Results
Analysis of 1,610 PSVT episodes found mean systolic BP changes of 1.8 mmHg for single 70 mg doses (N=440) and 0.0 mmHg for repeat dosing (N=714). Hypotension and syncope event rates were 0.4% and 0.2%, respectively, and all events resolved without medical intervention.
2. Regulatory Approval and Pipeline
CARDAMYST received FDA approval in December 2025 as the first self-administered nasal spray for adult PSVT conversion. Etripamil is now in Phase 3 trials for acute AFib with rapid ventricular rate in adults and Phase 2 studies for pediatric PSVT.
3. ACC.26 Presentation Details
Milestone will present a moderated poster on March 29 at ACC.26 showing minimal blood pressure effects of intranasal etripamil, followed by an expert theater session on March 30 exploring CARDAMYST’s emerging role in outpatient PSVT treatment outside the conference program.