Zavzpret is a nasal spray that could be perfect for those who have nausea when the migraine attacks start. This is the first and only approved gepant (CGRP receptor antagonist) nasal spray for people with acute migraine. More importantly, it is expected to be available very soon this year.
This latest approved migraine cure could be perfect for those with migraine symptoms that come with nausea that’s extreme enough to make swallowing pills challenging.
This is different from the other drugs that belong to the same class because zavegepant (Zavzpret) is a CGRP receptor antagonist, or “gepant.” This means that it’s is delivered as a nasal spray and it it gets absorbed quickly via the nose, bypassing the stomach. But like other gepants, it has some advantages over more than the popular migraine drugs because it doesn’t cause headaches from medication overuse.
The U.S. Food and Drug Administration (FDA) has given an approval for zavegepant last March 10. This is the first and only FDA-approved calcitonin gene-related peptide (CGRP) receptor antagonist adult nasal spray for the acute treatment of migraine with or without aura, as per a press release from Pfizer, the manufacturer of the brand.
The approval of zavegepant nasal spray means that there’s another option for those who are looking for treatment for their migraine, said Katherine Hamilton, MD. She is a neurologist and a headache specialist at MedStar Health in Washington, DC.
“We have seen in practice that similar CGRP-blocking medications can be very effective for both acute and preventive migraine treatment. Even though we already use similar medications, it is always nice to have more options to try, since sometimes patients respond better to one versus another medication in the same class,” Dr. Hamilton said.
In the pivotal phase 3 study, published online on February 16, 2023, in The Lancet Neurology, zavegepant was statistically far better than a placebo when it comes to pain treatment and from most bothersome symptom two hours after the treatment is taken. Some people in the trial also said that they found relief as soon as 15 minutes after using it.
It’s been estimated that almost 40 million Americans experience migraine, according to the American Migraine Foundation. Although just about anyone can have it, it has also been found that women are 3 times more likely than men.
Zavzpret – The First FDA-Approved Gepant Nasal Spray Treatment for Acute Migraine
Zavegepant is a medication for migraine called a gepant. Gepants basically block CGRP, a protein that carries pain signals along nerves and which generate the headache pain that’s linked to migraine.
In the clinical trials made, zavegepant showed sustained treatment benefits, good tolerability, and an alternative administration method, according to the lead author of the phase 3 study, Richard B. Lipton, MD. He is a professor in the department of neurology at the Albert Einstein College of Medicine in New York City. He explained this in a press release.
Dr. Lipton also shared that he owns stock in Biohaven, the company behind Zavzpret. He also consults for Pfizer, the company in charge of marketing it.
Migraine is not a general disease that shows the same set of symptoms for everyone. Zavzpret could fill an important gap in the options we now have to treat acute migraine, said Lipton.
“For people living with migraine, it is all about choice. The choice of drug mechanisms, the choice of drug target, the rapidity of onset of relief of pain and associated symptoms are all factors which influence choice. This addition gives doctors and patients more choices in pursuit of migraine relief,” Lipton added.
Zavzpret Effective for Pain Relief, Return to Normal Function, and Sustained Relief
The approval for Zavzpret was based on two pivotal double-blind, placebo-controlled studies with 2,079 people. Here, it was found that zavegepant was statistically far better to placebo on the co-primary endpoints of pain freedom (defined as a reduction of moderate or severe headache pain to no headache pain) and freedom from most bothersome symptom at two hours after taking it.
During the trials, the patients were asked to identify the most bothersome symptom (aside from pain) from a list that included items such as nausea, heightened sensitivity to light (photophobia), and heightened sensitivity to sound (phonophobia).
When the study reached phase 3, zavegepant proved to be statistically significant superior than placebo across 13 of 17 prespecified secondary outcome measures, and part of this were 15- and 30-minute pain relief and return to normal functioning after half an hour, return to normal function at 2 hours, and sustained pain freedom and relief.
Gepants Has Advantages as Acute Treatments
Gepants are a relatively new class of migraine medications which have been FDA-approved for acute (ubrogepant and rimegepant) and preventive (atogepant and rimegepant) treatment, said Lipton. Both the acute gepants are taken orally, he also said.
“The gepant class has a number of advantages as acute treatments: For starters, they have few side effects. And unlike triptans, they do not constrict blood vessels and so are not contraindicated in patients who have had heart attacks, stroke, or peripheral vascular disease. And unlike triptans and pain killers, they do not cause medication-overuse headache,” said Lipton.
“Zavzpret is the first gepant available by nasal spray,” Lipton explained. Nasal sprays seem to have more benefits for those who suffer from migraine attacks because they get in faster and start working faster as well, more than pills.
“The digestive system is sometimes paralyzed in migraine (gastric paresis), and zavegepant is absorbed from the nose even in people who have difficulty absorbing oral medications. Also, people with prominent nausea may have difficulty taking oral medications but have less trouble with a nasal spray,” Lipton noted.
Safety and Tolerability of Zavzpret
“Generally, both zavegepant and oral gepants have favorable tolerability profiles,” Lipton said.
The most common side effect that was experienced by 18 percent of participants of zavegepant was “taste disorders.” This meant that they experienced a distorted sense of taste or loss of taste. Other commonly reported side effects were nausea, nasal discomfort, and vomiting, all of which were reported by 4 percent or less when using the spray.
Those Who Can Most Benefit Zavzpret
People suffering from migraine and who need gepants are those with cardiovascular contraindications to triptans, those who experience medication-overuse headache, and those who don’t respond enough, or those who experience a variety of side effects with triptans, Lipton said.
“Within this group, the people who might be the best candidates for Zavzpret are looking for faster relief from pain, relief from associated symptoms, and restoration of function. This may be a particularly good choice in people with prominent nausea or vomiting, rapid onset of pain, or a disappointing response to oral agents,” he said.
When Zavzpret Will Be Available and Its Cost
Pricing will be known during its launch, which is said to be July 2023. They said that prices will be similar to other FDA-approved CGRP migraine medicines, according to a spokesperson from Pfizer.
The company has been actively engaged with their payors and pharmacy benefit managers to make sure that Zavzpret will be accessible to those who need it. There will also be patient support services and affordability programs so that they can fill their prescriptions. This will be part of Pfizer’s commitment to patient care, representative said.
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