Study 1

• Phase 3 double-blind, randomized, placebo-controlled clinical trial that evaluated
  ZAVZPRET 10 mg (N=623) nasal spray compared to placebo (N=646)¹
• ZAVZPRET nasal spray or placebo was self-administered to treat one migraine attack of moderate or severe headache pain intensity¹
• Co-primary endpoints included freedom from pain and most bothersome symptom (MBS) at 2 hours post-dose¹
• Select Prespecified Secondary endpoints presented include pain relief at 15 minutes, 30 minutes, 60 minutes, and 2 hours post-dose, return to normal function at 30 minutes, 60 minutes, and 2 hours post-dose, and sustained pain relief from 2-24 hours and 2-48 hours post dose²

Study 2

• Phase 2/3 double-blind, randomized, placebo-controlled, dose-ranging study that evaluated ZAVZPRET nasal spray 10 mg (N=391) compared to placebo (N=401).³
• Co-primary endpoints included freedom from pain and MBS at 2 hours post-dose¹

Pain intensity was measured on a 4-point scale (0-none, 1-mild, 2-moderate, 3-severe).³

Pain freedom was defined as a reduction in moderate or severe headache pain to no headache pain.¹

MBS freedom was defined as the absence of self-identified MBS (i.e., photophobia, phonophobia, or nausea).¹

Pain relief was defined as a reduction in migraine pain from moderate or severe severity to mild or none.¹

Participants rated functional disability based on a single item questionnaire using a 4-point scale (0-normal function, 1-mild impairment, 2-severe impairment, 3-required bedrest).¹

Participants were allowed to take rescue medications (i.e., NSAIDs, acetaminophen and/or an antiemetic) 2 hours after initial treatment. Other forms of rescue medication such as triptans were not allowed within 48 hours of initial treatment.¹

MBS=most bothersome symptom

Select secondary endpoint:
Rapid pain relief was observed at 2 hours vs placebo^2,3
Some patients saw relief in as little as 15 minutes²

Select secondary endpoint:
Rapid pain relief was observed at 2 hours vs placebo^2,3
Some patients saw relief in as little as 15 minutes²

In Study 1, pain relief at 15 minutes, 30 minutes, 60 minutes, and 2 hours were prespecified secondary endpoints.² Pain relief was defined as a reduction in migraine pain from moderate or severe severity to mild or none.¹

In Study 1, ZAVZPRET was tested for superiority versus placebo using a robust statistical analysis model, that applied a hierarchical gate-keeping procedure to control for type I statistical error rate at 0.05.² Pain relief at 15 minutes was not evaluated in Study 2.² The findings at 30 minutes, 60 minutes, and 2 hours were not replicated in Study 2.³

Select secondary endpoint:
Return to normal function was observed at 2 hours vs placebo¹ 
Some patients saw a return to normal function in as little as 30 minutes^2,4

In Study 1, return to normal function at 30 minutes, 60 minutes, and 2 hours were prespecified secondary endpoints.² Return to function was defined as the percentage of patients reporting normal function after dosing.² Participants rated functional disability based on a single item questionnaire using a 4-point scale (0-normal function, 1-mild impairment, 2-severe impairment, 3-required bedrest).¹

In Study 1, ZAVZPRET was tested for superiority versus placebo using a robust statistical analysis model, that applied a hierarchical gate-keeping procedure to control for type 1 statistical error rate at 0.05.² The findings at 30 minutes, 60 minutes, and 2 hours were not replicated in Study 2.³

Sustained relief that can last up to 48 hours^2,4

Select secondary endpoints

In Study 1, sustained pain relief from 2-24 hours and 2-48 hours were prespecified secondary endpoints. Sustained pain relief was reported as the percentage of patients reporting mild or no pain from a baseline pain of moderate or severe intensity, during 2-24 or 2-48 hour intervals.²

In Study 1, ZAVZPRET was tested for superiority versus placebo using a robust statistical analysis model, that applied a hierarchical gate-keeping procedure to control for type 1 statistical error rate at 0.05.² These findings were replicated in Study 2.³