Promising news for the 40 million Americans who live with chronic migraine. The US Food and Drug Administration (FDA) has approved Zavegepant, the first nasal spray for fast-acting migraine relief.
Zavegepant, which will be sold under the brand name Zavzpret, is the first and only calcitonin gene-related peptide (CGRP) receptor to be approved by the agency for migraine treatment. Small molecule CGRP receptor antagonists work by blocking the activity of a molecule called calcitonin gene-related peptide (CGRP), which is believed to play a key role in the development of migraines.
By blocking CGRP, these drugs can help to prevent or reduce the severity of migraines. In clinical trials published in The Lancet Neurology, the nasal spray provided migraine relief to patients within 15-30 minutes. In many of the 1,400 patients who participated in the studies, the effects lasted up to 48 hours.
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The spray offers an alternative to people who need pain relief but can’t take oral medications due to nausea or vomiting, Pfizer said in a statement. This adds to the current arsenal of acute migraine “rescue” medications including triptans, analgesics, and ergot alkaloids. Migraine preventatives include antihypertensives, anticonvulsants, and antidepressants, as well as Botox and CGRP injectables.
“The FDA approval of Zavzpret marks a significant breakthrough for people with migraine who need freedom from pain and prefer alternative options to oral medications,” said Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceuticals Business, Pfizer.
Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity. Symptoms often include nausea or vomiting and sensitivity to sound and light. Pfizer said the drug was approved to treat acute migraine with or without aura.
Common adverse reactions to the spray reported in trials included taste disorders, nausea, nasal discomfort, and vomiting. Some patients reported hypersensitivity reactions, including facial swelling and urticaria. The drug is also contraindicated in patients with a history of hypersensitivity to Zavegepant or to any of its chemical components.
Pfizer said the drug would become available in July 2023. The company did not offer any information about cost or possible coverage by health insurance.
