FDA Approves Nasal Spray for Acute Migraine

People who struggle with acute migraines, and can't take pills due to nausea, good news is on the way. The FDA approved Zavzpret, a nasal spray alternative, for adult patients.

Developed by the American pharmaceutical giant Pfizer, the nasal spray Zavzpret (zavegepant) is approved to treat acute migraine with or without aura in adult patients.

In the Phase 3 clinical trial, Zavzpret demonstrated statistically significant superiority to placebo. Two hours after the 10mg dose, 24% of participants in the Zavzpret group and 15% of patients in the placebo group achieved pain freedom, defined as a reduction of moderate or severe headache pain to no headache pain.

In addition, more participants in the Zavzpret group achieved freedom from their most bothersome symptoms.

Zavzpret belongs to a novel class of drugs known as calcitonin gene-related peptide (CGRP) receptor antagonists. This means that Zavzpret works by blocking CGRP, a protein that plays a role in triggering headaches associated with migraine.

While there are other FDA-approved CDRP antagonists, such as galcanezumab (Emgality) and erenumab (Aimovig), Zavzpret is the first and only nasal spray in this class of drugs.

"Among my migraine patients, one of the most important attributes of an acute treatment option is how quickly it works. As a nasal spray with rapid drug absorption, ZAVZPRET offers an alternative treatment option for people who need pain relief or cannot take oral medications due to nausea or vomiting, so they can get back to normal function quickly," says Kathleen Mullin, M.D., Associate Medical Director at New England Institute for Neurology & Headache, in a press release.

The most common side effects of Zavzpret occurring in at least 2% of patients were taste disorders, such as dysgeusia (a bad taste in the mouth) and ageusia (the loss of sense of taste), as well as nausea, nasal discomfort, and vomiting.

Migraine is a neurological disease that affects at least 39 million Americans and is classified as the second leading cause of disability globally by the World Health Organization. It is characterized by debilitating attacks lasting from four to 72 hours with multiple symptoms such as headaches of various intensity levels, often accompanied by nausea, vomiting, and sensitivity to the sound of light.

People who suffer from migraines deserve treatment that works and this new approved drug may be the help they need.


Leave a reply

Your email will not be published. All fields are required.