FDA Approves Nasal Spray for Migraines


Doctor with nasal spray | Image by Josep Suria/Shutterstock

The Food and Drug Administration has recently approved Zavzpret to quickly relieve migraine symptoms.

The nasal spray is manufactured by the multinational pharmaceutical and biotechnology corporation Pfizer, which announced the approval on March 10.

Noting that billions of people suffer from migraines worldwide, Angela Hwang, chief commercial officer and president of Pfizer’s global biopharmaceuticals business, said in the announcement, “The FDA approval of ZAVZPRET marks a significant breakthrough for people with migraine[s] who need freedom from pain and prefer alternative options to oral medications.”

This drug is the first designed to treat migraines by blocking the calcitonin gene-related peptide receptors that are linked to inflammation and associated with migraine pain.

The results of the latest trials of Zavzpret have been published in The Lancet. They suggested that, compared to a placebo, 10 mg of the drug was more effective at treating symptoms within 15 minutes and for up to 48 hours, per the release.

Dr. Kate Mullin, the primary investigator on the Zavzpret trial and associate medical director of the New England Institute for Neurology and Headache, noted, per USA Today, “Fifteen minutes is very quick, even for other nasal sprays.”

Migraines, according to the National Institute of Neurological Disorders and Stroke, are moderate to severe attacks of radiating, throbbing pain on one side of the head. They can also be accompanied by sensitivity to light, nausea, and vomiting. Some people experience migraines with aura, which can create visual disturbances or affect the ability to speak. If untreated, these attacks can last for up to 72 hours.

Some people suffer from migraines more frequently than others. They are thought to be hereditary and affect women three times more often than men. Some other causes of migraines include sudden changes in weather, stress, hormonal changes, poor sleep, and low blood sugar.

The trial run on Zavzpret involved 1,405 people experiencing moderate to severe migraines several times a month, per the release. One group was given a placebo, while the other was given Zavzpret. During the study, which ran from October 2020 to August 2021, participants were asked to rate their migraine headache pain on a four-point scale.

The study showed that approximately 24% of those who took Zavzpret experienced no pain two hours after treatment. In comparison, 15% of the people in the placebo group reported the same result.

Zavzpret may not be without side effects, however.

Rashmi Halker Singh, a neurologist at the Mayo Clinic in Phoenix and on the board of the American Headache Society, noted per NBC News that about a fifth of patients in the clinical trial reported experiencing an altered sense of taste, compared to just under 5% of patients who were given a placebo.

Another nasal spray used to treat migraines is Zolmitriptan, a triptan medication that works by lowering inflammation and constricting blood vessels to alleviate migraines. Some health experts warn that triptans may not be suitable for people with cardiovascular disease or high blood pressure due to how they function. One study linked them to a higher risk of ischemic events, including stroke.

Other medications come in pill form, which might not be suitable for those who suffer nausea and vomiting during their migraines.

As Frederick Godley III, otolaryngologist and president of the Association of Migraine Disorders, told USA Today that these symptoms can prevent oral medications from being absorbed properly.

The pricing of Zavzpret will be revealed when the medication is launched in July, per NBC News. To help it compete with other products on the market, the rapidity of the nasal spray will be highlighted.

Indeed, Biohaven, a subsidiary of Pfizer and the original developer of the drug, claimed per NBC News that Zavzpret is the “EpiPen of migraine.”

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