The U.S. Food and Drug Administration (FDA) approved Zavzpret™ (zavegepant – Pfizer) Nasal Spray on March 9, 2023. It is a calcitonin gene-related peptide (CGRP) receptor antagonist for treating adults who have acute migraines. The recommended dose is one spray (10mg) in one nostril as soon as possible after the headache begins. No more than one dose should be used in any 24-hour period and using more than eight sprays in any one-month period has not been shown to be safe. Zavzpret is not indicated to prevent migraines. Its launch is scheduled for July 2023, but pricing details are not yet available. Look here for complete prescribing information.
At a Glance
- Brand (Generic) Name: Zavzpret (zavegepant)
- Manufacturer: Pfizer
- Date Approved: March 9, 2023
- Indication: acute treatment of adults who have migraine with or without auras
- Dosage Forms Available: boxes of six10mg single-dose nasal sprayers
- Launch Date: July 2023
- Estimated Annual Cost: Not yet available
- Believed to affect about 12% of American adults – around 40 million people — at least occasionally, migraine headaches cause moderate-to-severe, often throbbing, head pain.
- Probably related to cyclic changes in hormone levels, women are three times as likely as men to have migraines, which also tend to run in families.
- Migraines may be preceded by auras – usually, vision changes, such as blinking lights; and they may be accompanied by nausea, vomiting, and sensitivity to light, noise, or temperature.
- During their headaches, about 90% of migraine sufferers cannot participate normally in regular activities, such as school or work.
- Direct and indirect costs of migraines may be as high as $36 billion per year, according to Health Union’s migraine.com.
- CGRP is a neuropeptide involved with vasodilation, inflammation, and pain transmission associated with migraine attacks. Blocking it helps to relieve migraine pain.
- In clinical trials, pain and other symptoms began to lessen after as little as 15 minutes for some patients using Zavzpret. Relief persisted for up to 48 hours.
- Side effects, such as nasal irritation, nausea, and taste disturbances, generally were mild. A few patients had allergic reactions that caused facial swelling and itching.
- Ubrelvy® (ubrogepant – AbbVie) and Nurtec® ODT (rimegepant – Biohaven Pharmaceuticals) are orally administered CGRP inhibitors approved to treat migraines once the headaches have started. In June 2021, Nurtec ODT received an additional indication to prevent migraine attacks.
- Three self-administered, subcutaneously (SC) injected CGRP inhibitors, Aimovig® (erenumab-aooe – Amgen), Emgality® (galcanezumab-gnlm – Eli Lilly), and Ajovy® (fremanezumab-vfrm – Teva) was FDA approved in 2018 to prevent migraines. Approved in 2020, another CGRP inhibitor, Vyepti® (eptinezumab-jjmr – Lundbeck), requires intravenous (IV) administration every three months to prevent migraine attacks. An oral CGRP blocker, Qulipta™ (atogepant), got FDA approval in 2021 for migraine prevention.