Zavzpret (Zavegepant) Migraine Nasal Spray from Pfizer Gets FDA Nod

Zavzpret (Zavegepant) Migraine Nasal Spray from Pfizer Gets FDA Nod

Zavzpret is a breakthrough for people with migraines — it drastically reduces pain and offers an alternative to oral medications.

Pfizer recently announced that their novel migraine nasal spray Zavzpret (zavegepant), received US Food and Drug Administration (FDA) approval for the acute treatment of migraines (with or without aura) in adults. Zavzpret is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist indicated for the treatment of migraines.

A migraine is an extremely painful headache that can lead to severe throbbing or pulsing sensations (usually on one side of the head). Migraines may cause nausea, vomiting and sensitivity to light and sound. Migraines can last for hours to days, heavily interfering with daily life. About 25 to 30 percent of people experience auras before a migraine begins. Auras are visual changes like light flashes, blind spots, vision loss, as well as facial or body numbness, that act as a “warning” of impending migraines.

Migraines are one of the most common neurological disorders, affecting over a billion individuals globally. It is most prevalent in females and young adults and is associated with several comorbidities including stress and poor sleep.

After a migraine, people often feel drained and confused for several days, and sudden head movements may bring the pain back. Evidently, there is a significant negative impact to one’s quality of life. The approval of Zavzpret is a breakthrough for people with migraines. This new migraine nasal spray drastically reduces pain and offers an alternative to oral medications, a benefit to those who are unable to swallow pills.

Efficacy and Safety of Zavegepant

Zavzpret is a novel class of drugs for treating migraines. Falling under the category of CGRP receptor antagonists, Zavzpret has a unique mode of action and is an alternative to other treatment options that patients may have contraindications towards (e.g., triptans, serotonin receptor agonists).

CGRP receptor antagonists are selective and structurally unique small molecules with high affinity — they block the peptides involved in generating the pain and inflammation associated with migraines by binding to the CGRP receptors. Additionally, CGRP receptor antagonists have not been associated with medication overuse or rebound headaches.

The approval of Zavzpret is based on two randomized, double-blind, placebo-controlled studies that demonstrate its efficacy, tolerability and safety. In both studies, zavegepant performed statistically better than the placebo in co-primary endpoints: freedom from pain (defined as the reduction of headache pain to no headache pain) and freedom of most bothersome symptoms (self-identified) two hours post-dose.

The Phase III study was published in The Lancet Neurology journal. Overall, two hours post-treatment, 24 percent of zavegepant-treated patients compared to 15 percent of placebo-treated participants demonstrated pain freedom. Results from 1405 eligible patients demonstrated broad efficacy and statistically significant superiority to the placebo treatment across 13 of 17 outcome measures from the study. One of these endpoints was the early time point endpoints, which included pain relief within 15 and 30 minutes, with return to normal function at 30 minutes and return to normal function at two hours. Additionally, it was superior in the durable efficacy endpoint, the parameters of which were sustained freedom from pain for two to 24 and two to 48 hours.

Zavegepant was generally well tolerated in the studies, with the most common adverse reactions reported in at least two percent of patients being taste disorders, nausea, nasal discomfort and vomiting. The medication should not be used by patients who have a history of hypersensitivity to zavegepant (e.g., facial swelling and urticaria).

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A New, Fast-Acting Migraine Nasal Spray

Kathleen Mullin, MD, Associate Medical Director at New England Institute for Neurology & Headache stated, “Among my migraine patients, one of the most important attributes of an acute treatment option is how quickly it works. As a nasal spray with rapid drug absorption, Zavzpret offers an alternative treatment option for people who need pain relief or cannot take oral medications due to nausea or vomiting, so they can get back to normal function quickly.”

The approval of Zavzpret is also an expansion of Pfizer’s migraine portfolio, which already consists of an oral therapy for acute and preventative migraine treatment for adults. Zavzpret will be available in pharmacies in July 2023. The price of Zavzpret will be comparable to other CGRP migraine treatments, which are currently priced at around $6900 per year or $575 per month.