Milestone Pharmaceuticals has announced the initiation of the Phase 3 NODE-303 open-label safety study of the company’s intranasal etripamil for the treatment of paroxysmal supraventricular tachycardia (PSVT). NODE-303 is the third of three trials in the Phase 3 program for etripamil. NODE-301 was initiated in August 2018, and NODE-302 got underway in December 2018.
NODE-303 is expected to enroll as many as 1,500 patients who will self-administer the etripamil nasal spray during PSVT episodes without any medical supervision. In addition to safety, the trial will evaluate efficacy, quality of life, and pharmacoeconomics. While NODE-301 includes a requirement for an in-office safety test dose, NODE-303 will not have that requirement.
Milestone Pharmaceuticals President and CEO Joseph Oliveto commented, “Commencement of enrollment in NODE-303 marks an important step forward for our Phase 3 program of etripamil in PSVT, where current standards of care are restricted to the burdensome and costly acute care setting. We believe etripamil has the potential to alter the PSVT treatment paradigm, providing patients with a self-administered intervention to effectively terminate PSVT episodes wherever and whenever they occur. We remain focused on the execution of the entirety of the program, and continue to expect topline results from NODE-301 in the first half of 2020.”
Read the Milestone Pharmaceuticals press release.
