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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 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 placebo

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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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

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.

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

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.
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.

Please see Full Prescribing Information.