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FDA approved Zavzpret (zavegepant) for Acute Treatment of Migraine in AdultsFDA approved new nasal spray Zavzpret for quick migraine relief in adults.

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Key Takeaway
Consider Zavzpret for acute migraine relief, but limit use to 8 migraines per 30 days due to lack of safety data.

The FDA has approved Zavzpret (zavegepant) nasal spray for the acute treatment of migraine with or without aura in adults, offering a new non-oral option for patients who need rapid relief. Zavzpret is a calcitonin gene-related peptide (CGRP) receptor antagonist, a class of drugs that block the effects of CGRP, a protein involved in migraine attacks. The approval was based on two randomized, double-blind, placebo-controlled trials (Study 1 and Study 2) that enrolled over 2,000 adults with migraine. In both studies, a single 10 mg dose of Zavzpret was statistically superior to placebo in achieving pain freedom and freedom from the most bothersome symptom (photophobia, phonophobia, or nausea) at 2 hours post-dose. For clinicians, Zavzpret provides an intranasal formulation that may be particularly useful for patients who prefer non-oral routes or have nausea during attacks. However, the label notes that the safety of treating more than 8 migraines in a 30-day period has not been established, and the drug is not intended for preventive use.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Zavzpret (zavegepant) is a calcitonin gene-related peptide (CGRP) receptor antagonist. It works by blocking the binding of CGRP to its receptor, which is thought to play a role in the pathophysiology of migraine.

Indication & Patient Population

Zavzpret is indicated for the acute treatment of migraine with or without aura in adults. It is not indicated for the preventive treatment of migraine.

Dosing & Administration

The recommended dose is 10 mg given as a single spray in one nostril, as needed. The maximum dose in a 24-hour period is 10 mg (one spray). The safety of treating more than 8 migraines in a 30-day period has not been established.

Key Clinical Trial Data

Efficacy was demonstrated in two randomized, double-blind, placebo-controlled trials (Study 1 and Study 2). In Study 1 (N=623 Zavzpret, N=646 placebo), the coprimary endpoints of pain freedom and most bothersome symptom (MBS) freedom at 2 hours were met: pain freedom in 23.6% vs 14.9% (difference 8.8%, p<0.001) and MBS freedom in 39.6% vs 31.1% (difference 8.7%, p=0.001). In Study 2 (N=391 Zavzpret, N=401 placebo), pain freedom was 22.5% vs 15.5% (p=0.011) and MBS freedom was 41.9% vs 33.7% (p=0.016). Additional endpoints in Study 1 included pain relief at 2 hours (58.7% vs 49.7%, p=0.001), normal function at 2 hours (35.8% vs 25.6%, p<0.001), and sustained pain freedom from 2 to 48 hours (12.4% vs 8.7%, p=0.031).

Warnings & Contraindications

No specific warnings or contraindications are mentioned in the provided label text. However, as with any medication, clinicians should consider potential hypersensitivity reactions, though not reported in the label.

Place in Therapy

Zavzpret offers an intranasal CGRP receptor antagonist for acute migraine treatment, providing an alternative for patients who may have nausea or prefer non-oral administration. It is not for prevention. The label notes that safety beyond 8 migraines per 30 days is not established, so it should be used accordingly.

The U.S. Food and Drug Administration (FDA) has approved a new medication called Zavzpret (zavegepant) for the acute treatment of migraine with or without aura in adults. This means it is used to stop a migraine attack once it has started, not to prevent future attacks. Zavzpret comes as a nasal spray, which is a new option for people who prefer not to take pills, especially if they have nausea during a migraine.

Zavzpret belongs to a class of drugs called CGRP receptor antagonists. These drugs work by blocking the effects of a protein called CGRP, which is involved in causing migraine pain and symptoms. In clinical studies involving over 2,000 adults, a single 10 mg dose of Zavzpret was more effective than a placebo at providing pain relief and freedom from the most bothersome symptom (such as sensitivity to light or sound, or nausea) within two hours.

This approval is significant because it provides a fast-acting, non-oral treatment option. Many people with migraines experience nausea, which can make swallowing a pill difficult. The nasal spray may be easier to use during an attack. However, the safety of using Zavzpret for more than eight migraines in a 30-day period has not been studied, so it is not intended for frequent use.

If you suffer from migraines, this new option might be worth discussing with your doctor. They can help you decide if Zavzpret is right for you, based on your medical history and the pattern of your migraines. Remember, this medication is for treating an active migraine, not for preventing them, and it should be used as directed by your healthcare provider.

What this means for you:
Zavzpret is a new nasal spray that can stop a migraine in its tracks, but it's not for prevention and you should talk to your doctor.

Study Details

Study typeFda approval
PublishedMar 2023
View Original Abstract ↓
1 INDICATIONS AND USAGE ZAVZPRET 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. ZAVZPRET is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults. ( 1 ) Limitations of Use ZAVZPRET is not indicated for the preventive treatment of migraine. ( 1 )
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