The FDA just approved the first fast-acting migraine nasal spray.

The World Health Organization (WHO) ranks migraine as the second leading cause of disability in the world. Treatment is more or less effective depending on the range of medications used and the response of the body, but some people may not be able to take medication due to symptoms associated with headache attacks, such as vomiting. Researchers have recently developed the very first migraine nasal spray, which has just been approved by the US FDA. It promises to revolutionize the treatment of migraine. The results of this large-scale use will be critical to the application for approval by the European health authorities.

Migraine affects approximately 10% of the world’s population and is most common in people between the ages of 20 and 50. It occurs about 3 times more often in women than in men.

As a reminder, migraines are often characterized by moderate to severe throbbing headaches in a specific area of ​​the skull. It lasts from 4 to 72 hours and is associated with symptoms such as sensitivity to light (photophobia) or sound (phonophobia), nausea, and vomiting. Some people experience visual disturbances (auras) that may appear as zigzag lines or flashing lights before or during a migraine.

Migraines are most commonly treated with pain medications such as paracetamol, aspirin, and ibuprofen, or NSAIDs (such as naproxen). Migraines that do not respond to these drugs can be treated with a class of drugs called triptans. They cause blood vessel constriction, reversing the dilation of blood vessels that is part of the migraine process. But again, some people do not respond to or tolerate this class of medication.

Intranasal drugs may offer treatment options for migraine for which oral drugs are ineffective, slow-acting, or intolerable due to nausea and vomiting. Recently, the US Food and Drug Administration (FDA) approved Pfizer’s fast-acting nasal spray for the treatment of migraine. A phase 3 study of the drug showed that it relieves pain in some migraine sufferers in as little as 15 to 20 minutes. The study was published in The Lancet Neurology.

Encouraging Research

The FDA approval is based on two pivotal, randomized, double-blind studies (neither clinicians nor patients knew who received the placebo) that established the efficacy, tolerability, and safety profiles of ZAVZPRET for the treatment of acute migraine.

ZAVZPRET is the first and only calcitonin gene-related peptide (CGRP) antagonist nasal spray for the emergency treatment of adult migraine. Calcitonin gene-related peptide (CGRP) receptor antagonists, also known as hepants, are a new class of drugs that target CGRP receptors that are thought to play a role in pain and migraine.

In these studies, VZZPRET was statistically superior to placebo in reducing moderate to severe headaches, eliminating headaches, and reducing most bothersome symptoms two hours after dosing. Specifically, of those who received the spray, 24% reported pain relief after two hours, compared with 15% of those who received a placebo.

This spray has also shown broad efficacy for pain relief between 15 and 30 minutes after ingestion and return to normal function after 30 minutes, as well as long-term efficacy (no sustained pain for 2-24 hours and 2-48 hours, and persistent pain relief).

However, as stated in a Pfizer press release, the difference between RELATED and placebo was not significant in assessing return to normal 15 minutes after administration. Thus, these secondary endpoints have not been formally tested and need further study.

Hope for people with chronic migraine

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Kathleen Mullin, MD, assistant medical director of the New England Institute of Neurology and Headache, explains: “When a migraine occurs, it has a significant negative impact on a person’s daily life. In my migraine patients, one of the most important attributes of a treatment is its speed of action. ZAVZPRET’s fast-absorbing nasal spray offers an alternative treatment option for people who are unable to take oral medications due to nausea or vomiting.”

In addition, ZAVZPROT was well tolerated in clinical trials. The most common adverse reactions reported in only 2% of treated patients and at a higher frequency than placebo were taste disturbances (including dysgeusia and ageusia), nausea, nasal discomfort, and vomiting.

However, SUPPLY is contraindicated in patients with a history of hypersensitivity to gepant or any of its components. Hypersensitivity reactions, including facial edema and urticaria, have occurred with the use of ZAVZPROT in clinical studies. New studies will start soon and will be required to apply for approval with European health authorities. In the US, the spray will be available in pharmacies in July 2023.

The Lancet Neurology

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