Business
Milestone Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Clinical and Corporate Update
- Phase 3 RAPID trial of etripamil in patients with PSVT achieved primary efficacy endpoint; safety and tolerability data from repeat dose administration
About this update from Milestone Pharmaceuticals Inc.
[{"type":"text","content":"- Phase 3 RAPID trial of etripamil in patients with PSVT achieved primary efficacy endpoint; safety and tolerability data from repeat dose administration consistent with prior studies utilizing single-dose administration of etripamil\n- Analyses from etripamil Phase 3 PSVT studies featured during Late-Breaking session at AHA Scientific Sessions 2022 demonstrated significant reductions in emergency department utilization for etripamil-treated patients\n- Company plans to submit NDA for etripamil in PSVT to the U.S. FDA in mid-2023 pending Agency feedback\nMONTREAL and CHARLOTTE, N.C., Nov. 10, 2022 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today reported financial results for the third quarter ended September 30, 2022, and provided a clinical and corporate update.\n\"The positive feedback we received from both clinicians and patient advocacy groups following the presentation of further RAPID data at the American Heart Association (AHA) meeting earlier this week strengthen our conviction that etripamil has the potential to serve as a promising option for patients with paroxysmal supraventricular tachycardia (PSVT),\" said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. \"We are keenly focused on preparations for our planned New Drug Application (NDA), which we expect to submit to the U.S. Food and Drug Administration (FDA) in mid-2023 pending agency feedback.\"\nRecent UpdatesAnnouncement of Positive Topline Efficacy and Safety Results from Phase 3 RAPID Clinical Trial of Etripamil Nasal Spray in Patients with PSVT. In October 2022, the Company announced that the Phase 3 RAPID clinical trial of etripamil, a new chemical entity and Milestone's lead investigational product, in patients with PSVT met its primary endpoint, with 64.3% of patients self-administering etripamil converting to sinus rhythm within 30 minutes compared to 31.2% on placebo (HR = 2.62, p","length":2987,"tagName":"div"}]