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Safety &
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Prescribing InformationPatient Information Instructions for UseIndication Press Release
EfficacyEfficacyStudy Design

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

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

Select secondary endpoint:
Rapid pain relief was observed at 2 hours vs placebo2,3
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 minutes2,4

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 hours2,4

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

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See the safety profile
 Learn more References:Zavzpret. Package insert. Pfizer Inc.Lipton RB, Croop R, Stock DA, et al. Safety, tolerability, and efficacy of zavegepant 10 mg nasal spray for the acute treatment of migraine in the USA: a phase 3, double-blind, randomised, placebo-controlled multicentre trial. Lancet Neurol. 2023;22(13):209-217. doi:10.1016/S1474-4422(22)00517-8Croop R, Madonia J, Stock JR, et al. Zavegepant nasal spray for the acute treatment of migraine: a phase 2/3 double-blind, randomized, placebo-controlled dose-ranging trial. Headache. 2022;62(9):1153-1163. doi:10.1111/head.14389Mullin K, Croop R, Pavlovic JM, et al. Efficacy and safety of zavegepant nasal spray for the acute treatment of migraine: results of phase 3 double-blind, randomized, placebo controlled trial. Oral presentation at 2022 American Headache Society Meeting.

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INDICATION

ZAVZPRET® (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.

Important Safety InformationContraindications: Hypersensitivity to ZAVZPRET or any of its components.

Warnings and Precautions
Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, facial swelling, and urticaria, have occurred in patients treated with ZAVZPRET. If a hypersensitivity reaction occurs, discontinue ZAVZPRET and initiate appropriate therapy.

Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists in the postmarketing setting.

Monitor patients for new-onset hypertension or worsening of pre-existing hypertension and consider whether discontinuation is warranted.

Raynaud’s Phenomenon: Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists.

If signs or symptoms of Raynaud’s phenomenon develop, discontinue ZAVZPRET. Patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms. 

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: Pregnancy: It is not known if ZAVZPRET can harm an unborn baby. Lactation: It is not known whether ZAVZPRET passes into breast milk. 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.
IndicationZAVZPRET (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.

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Prescribing Information.