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Study 1
Study 2
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
One spray to rapidly reclaim their moments1
Co-primary endpoints:
Freedom From Pain and Most Bothersome
Symptom at 2 Hours1
Co-primary endpoints:
Freedom From Pain and Most Bothersome
Symptom at 2 Hours1
MBS=most bothersome symptom
Select secondary endpoint:
Rapid pain relief was observed at 2 hours vs placebo2,3
Some patients saw relief in as little as 15 minutes2
Rapid pain relief was observed at 2 hours vs placebo2,3
Some patients saw relief in as little as 15 minutes2
Study 1: Percentage of Patients Achieving Pain Relief Over Time2,4
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, ZAVPRET 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 minutes2,4
Study 1: Percentage of Patients Achieving Return to Normal Function Over Time2,4
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 hierarchal 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 hours2,4
Select secondary endpoints
Study 1: Percentage of Patients Achieving Sustained Pain Relief Over Time2,4
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 hierarchal gate-keeping procedure to control for type 1 statistical error rate at 0.05.2 These findings were replicated in Study 2.3
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PP-MCL-USA-0367
ZAVZPRETTM (zavegepant) is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use: ZAVZPRET is not indicated for the preventive treatment of migraine.