- Federal regulators are expected to vote soon on a new nasal spray for the treatment of acute migraine.
- Zavegepant has performed well in clinical trials.
- It works by blocking a peptide that carries pain signals.
- Experts say a nasal spray could be beneficial to people who get nauseous from taking oral medications for migraine.
A nasal spray may soon be approved by the Food and Drug Administration (FDA) for the treatment of acute migraine.
The drug, known as zavegepant, showed promising results in a phase 2/3 clinical trial last year.
“Zavegepant may have a therapeutic role in the acute treatment of migraine as an effective alternative to oral and parenteral agents. Patients most likely to benefit from the use of zavegepant will be adults seeking a rapid onset of action (e.g., people regularly awakened by attacks) and those whose attacks typically involve marked gastrointestinal distress,” the clinical trial researchers reported.
“The nasal spray formulation may be a particularly advantageous nonoral, needle-free approach to avoid exacerbations of nausea or vomiting, facilitate drug administration, and eliminate the effects of gastroparesis on drug absorption,” they added.
How zavegepant treats migraine
Zavegepant is a form of gepant, a relatively new form of migraine treatment.
In migraine, a protein known as calcitonin gene-related peptide (CGRP) carries pain signals along nerves, causing the pain experienced in these headaches.
Gepants like Zavegepant work by stopping the CGRP from initiating those pain signals.
“Rather than working on several different parts, in nerves, neurons, the brain or other parts of the body, it’s trying to target one specific molecule in the body that they have found in research to be elevated in migraine patients. So, of course, they ask the question ‘if this CGRP molecule is elevated in migraine patients what would happen if we blocked that CGRP molecule and only that one?’” Dr. Elizabeth Imma Iziegbe Ekpo, a clinical assistant professor in the Department of Neurology and Specialist in Headache Medicine at the University of California Davis, told Healthline.
Treating nausea associated with migraine
The researchers of the clinical trials say that in the acute treatment of migraine, symptoms such as vomiting and nausea can delay the use of oral medications and may also result in slower absorption of medications.
Some oral medications for migraine, such as triptans, can cause nausea.
Having a gepant nasal spray available may encourage earlier treatment as well as reduce the risk of treatment-related nausea or vomiting.
The advantages of a nasal spray
Dr. Leon S. Moskatel, a clinical assistant professor in the Division of Headache and Facial Pain in the department of Neurology and Neurological Sciences at Stanford University School of Medicine in California, said that, if approved, zavegepant could prove beneficial to many people who have yet to find effective treatments.
“As headache medicine physicians, we love seeing new headache therapeutics come to market because they give us more options to help our patients. Zavegepant is the first non-orally administered member of the gepant family of medication,” he told Healthline.
“Nasal sprays can be great options for patients for whom nausea or vomiting are prominent features of their migraine,” Moskatel added. “In these patients, oral medications can be difficult to ingest or worse, vomited up. Additionally, nasal sprays can be faster-acting than oral medications so patients with rapid onset pain or visual aura symptoms may benefit, too.”
The pain of migraine
More than 10% of people worldwide are affected by migraine.
It most commonly occurs in people aged 20 to 50 and is three times more common in women than men.
In the United States, 17% of women and 5.6% of men have reported experiencing migraine symptoms.
While there are some effective treatments for migraine, these don’t work for everyone.
“We have effective medications for the acute treatment of migraine. The seven members of the triptan class of medication have been the go-to for countless patients over the past 20 to 30 years. However, not all patients have done well with these medications due to a lack of efficacy or side effects. Many of these patients have instead done well with the more recent gepant class of medication. Zavegepant will give those patients a non-oral and faster-onset option,” Moskatel said.
Awaiting FDA approval
Zevagepant is still awaiting a decision from the FDA, but Ekpo is hopeful the drug will be approved.
“At this point, I really hope that this medication is approved and approved quickly because I’d like to be able to offer additional options for my patients,” she said.
“I have seen some help from the other CGRP antagonists, but I always want to have options with people who can’t tolerate things that have to be taken orally. It would be very nice and helpful to patients to have this CGRP nasal spray option… I hope it’s approved,” Ekpo added.
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