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
One spray to rapidly reclaim their moments1
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Co-primary endpoints: Freedom From Pain and Most Bothersome Symptom at 2 Hours1 |
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| 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 placebo 2,3
Some patients saw relief in as little as 15 minutes2
Rapid pain relief was observed at 2 hours vs placebo 2,3
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
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.
Warnings and Precautions: Hypersensitivity reactions, including facial swelling and urticaria, have occurred with ZAVZPRET. If a hypersensitivity reaction occurs, discontinue ZAVZPRET and initiate appropriate therapy.
Adverse Reactions: Most common adverse reactions (occurring in ≥2% of patients treated with ZAVZPRET and greater than placebo) for ZAVZPRET vs placebo were taste disorders including dysgeusia and ageusia (18% vs 4%), nausea (4% vs 1%), nasal discomfort (3% vs 1%), and vomiting (2% vs 1%).
Drug Interactions: Avoid use with drugs that inhibit or induce OATP1B3 or NTCP transporters. Avoid use of intranasal decongestants; if unavoidable, administer intranasal decongestants at least 1 hour after ZAVZPRET administration.
Use in Specific Populations: Hepatic Impairment: Avoid use in patients with severe hepatic impairment. Renal impairment: Avoid use of ZAVZPRET in patients with creatinine clearance (CLcr) less than 30 mL/min.
Please click here for full Prescribing Information.
Limitations of Use: ZAVZPRET is not indicated for the preventive treatment of migraine.
Please see Full Prescribing Information.