FDA Approves Zavzpret, a New Fast-Acting Nasal Spray to Treat Migraine

• The Food and Drug Administration (FDA) approved Zavzpret, a new nasal spray for the treatment of migraine, last week.

• Zavzpret (zavegepant), from drugmaker Pfizer, is the first CGRP inhibitor intranasal spray to be approved by the FDA for migraine in adults.

• The medication is expected to be available for patients beginning in July.

People with migraine have a new FDA-approved treatment option in the form of a fast-acting nasal spray, drugmaker Pfizer announced last week.

Zavzpret (zavegepant) is part of a newer class of migraine medications. It’s the first CGRP inhibitor intranasal formulation to be approved by the FDA for treatment of migraine, and the medication is expected to be available for patients beginning in July.

“It’s great for people living with migraine to have another option available,” Abby Metzler, MD, assistant professor of neurology at the University of Minnesota Medical School, who was not involved in the study, told Health. “It’s, in general, an under-diagnosed and under-treated condition. So the more options we have, the better.”

Here’s what experts had to say about how Zavzpret works in the body, who might be a good candidate for the medication, and how people with migraine can access it.

How Zavzpret Works

The new medication is what’s known as a CGRP inhibitor. It works by targeting CGRPs—calcitonin gene-related peptides—which are small proteins in the nervous system known to play a role in migraine pain. People who have migraine typically have elevated CGRP levels in their plasma, saliva, and tear fluid.

“Calcitonin gene-related peptide (CGRP) is circulating in everybody, but it seems to be more active in patients that have headaches,” said Kathleen Mullin, MD, associate medical director at the New England Institute for Clinical Research and lead clinical trial investigator for the medication’s phase 3 trial.

CGRP inhibitors—sometimes known as “gepants”—bind to the CGRP receptors in the body, ultimately blocking CGRP so it can’t initiate or worsen a headache, Dr. Mullin told Health.

Knowledge about the relationship between CGRP and migraine is relatively new, and so are the treatments. There are two other gepants that people can take to help with acute migraine—rimegepant and ubrogepant—though both are oral medications. Zavzpret offers similar results, just in a nasal spray formulation.

This formulation may even give Zavzpret a slight leg up on these other similar medications. Other nasal spray migraine medications tend to be absorbed faster than pills, said Chelsea Stone, DO, assistant clinical professor of neurology and headache specialist at Keck Medicine of USC who was not involved with the study. This means that nasal spray formulations may provide faster relief, which is crucial when someone is in pain from a migraine.

To use Zavzpret, adults are instructed to dispense a single spray into one nostril at the onset of a migraine. Zavzpret should not be taken more than once during a 24-hour period; the safety of taking Zavzpret eight times over a 30-day period has not been established.

Related:What Causes Migraine?

How Effective Is Zavzpret?

In its phase 3 clinical trial, Pfizer tested the new migraine medication among 1,269 adults who had between two and eight migraines monthly. They were split evenly into two groups—one took a 10mg dose of the nasal spray medication, and the other took a placebo when they started to feel a moderate-to-severe migraine attack coming on.

For the Zavzpret group, two hours after taking a dose of the nasal spray, 24% said they were pain-free, and 40% reported that their most bothersome migraine symptom went away. In comparison, 15% of people from the placebo group said they were pain-free and 31% said they were free of their most bothersome symptom.

But symptom relief happened sooner than the two-hour mark for some people who took Zavzpret: 16% of participants said they felt some pain relief just 15 minutes after taking the medication; after an hour, 43% had some pain relief.

In addition to being fast-acting, relief from Zavzpret also seemed to be long-lasting. Though the amount of time that people felt symptom relief varied, 36% of people who took the medication reported feeling relief for up to two days.

As with many medications, Zavzpret was found to have a few side effects. In the clinical trial, 3% of people experienced nausea, 4% experienced nasal discomfort, and 21% had altered or unpleasant taste. However, these are fairly common both among nasal sprays and migraine drugs, experts said, so they're not overly concerned with these reports. Zavzpret is, generally speaking, “really well tolerated,” Dr. Metzler said.

“When you're experiencing moderate-to-severe pain and headache, these things are usually no big deal compared to pain relief,” Dr. Mullin added.

Related:18 Signs of a Migraine

Who Might Benefit Most From Zavzpret?

Pfizer’s clinical trial compared Zavzpret to placebo, so it’s still to early to say how the medication stacks up to other options, but it may be a promising option for a number of people.

In addition to the fact that nasal sprays allow the medication to be absorbed in the body faster, they also make things less complicated for people who struggle to take oral medications.

“A lot of migraine patients suffer from nausea and vomiting. And then you tell them to take an oral medication. And that can be limiting,” Dr. Stone told Health. “This is a really good option for those patients—and there are a lot of them.”

Even for those people who don’t experience nausea, a large majority of people with migraine experience gastroparesis, Drs. Mullin and Stone said, which means that gut function slows down. This means it can’t absorb that oral medication as quickly as it normally would.

CGRP inhibitors in general may also be good alternatives for people who can’t take triptans, which are another common form of migraine medication. Triptans help alleviate migraine symptoms by constricting blood vessels, Dr. Mullin explained, so they’re not safe for people who have a history of cardiovascular issues.

These medications also don’t cause overuse headaches, the experts said, which is a big deal for people who have to take migraine medication more frequently.

“You’re trying to prevent a headache from happening or from getting worse. What’s interesting is if you take [some medications] too often, you can actually cause another kind of headache problem,” Dr. Stone said. “What’s really cool about this entire class of medications is that we’re not seeing any risk of medication overuse headache.”

Again, it’s not clear how Zavzpret specifically stacks up against other CGRP, triptans, or other migraine medications, and more research is needed. And there’s even some evidence that triptans may be more effective than gepants, though the latter has fewer negative side effects.

“There’s certain categories of patients that could really benefit from it,” Dr. Mullin said. “But the truth is, I think everybody could use it as part of their [migraine] toolkit.”

Related:What To Know About the Health Risks of Migraines

Accessing Zavzpret

Zavzpret is set to become available in pharmacies this July, though there are still some questions about what access to the medication may look like.

Two other CGRP inhibitors can prevent migraine, but for now, it’s unclear if Zavzpret can do the same, Dr. Stone said. For now, it’s going to be used as a one-time treatment to be implemented only once a migraine starts.

Insurance and other logistical factors may impact how many doses of Zavzpret a person is able to access come this summer, Dr. Stone explained. But ideally, someone would be able to have a dose on hand when they start to experience migraine symptoms.

If someone is interested in the nasal spray medication, it’s best to get in contact with a headache specialist, Drs. Stone and Mullin said, since the drug is so new. The specialist can help walk someone through the process of accessing the medication if they deem that it’s a good health decision.

“[For] patients who need a nasal spray route of administration or for whom triptans are not effective,” Dr. Metzler said, “talking to their primary care physician, or neurologist, or headache specialist about this option would be the way to go.”

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