Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia. NODE 301 and RAPID Studies

• Participants who met all of the following criteria were eligible to participate in the study:

• Male or female participants at least 18 years of age;

• Electrographically documented history of PSVT (e.g., electrocardiogram \[ECG\] obtained during an episode of PSVT, Holter monitoring, loop recorder, etc). If participant had a prior ablation for PSVT, participant had to have documented ECG evidence of PSVT post-ablation;

• History of sustained episodes of PSVT (i.e., typically lasting approximately 20 minutes or longer);

• Females of childbearing potential who were sexually active with a male partner who were not surgically sterile (i.e., vasectomy) had to agree to use a highly effective form of contraception from the time of signed informed consent until 30 days after the last administration of study drug. Females of childbearing potential had to have a negative serum pregnancy test result at the Screening Visit and at the Final Study Visit, a negative urine pregnancy test at the Test Dose Randomization Visit and had to use a highly effective form of contraception between the visits.

• The following categories defined females who were NOT considered to be of childbearing potential:

⁃ Premenopausal females with 1 of the following:

∙ Documented hysterectomy,

‣ Documented bilateral salpingectomy or tubal ligation; or

‣ Documented bilateral oophorectomy, or

⁃ Postmenopausal females, defined as having amenorrhea for at least 12 months without an alternative medical cause;

• Male participants, except those who were surgically sterile, had to use an approved highly effective form of contraception during the 3 days after any study drug administration; and

• Signed written informed consent.