by The US Food and Drug Administration has approved a world’s first fast-acting nasal spray to treat migraines, pharmaceutical giant Pfizer announced on Friday.
Pfizer noted in a statement that the drug, called Zavzpret, is expected to be available in pharmacies in July 2023.
“The FDA approval of Zavzpret marks a significant breakthrough for people with migraines who need freedom from pain and prefer alternatives to oral medications,” said Angela Hwang, the pharmaceutical company’s chief commercial officer, in a statement.
It is estimated that over 40 million people in the US suffer from migraines, and the World Health Organization ranks the condition as one of the top 10 most disabling medical conditions.
Migraines are characterized by debilitating attacks that can last four to 72 hours, with symptoms such as a throbbing headache of moderate to severe pain intensity, sometimes accompanied by nausea or vomiting.
Researchers have tested nasal sprays as an option to treat migraines in people for whom oral medications are ineffective, slow-acting, or unbearable due to nausea and vomiting.
In a phase 3 clinical trial, Pfizer found that Zavzpret — which is a new class of small molecule drugs — was superior to placebo in reducing migraine pain two hours after ingestion.
The study, the results of which were recently published in the journalThe Lancet Neurology, also found pain relief after just 15 minutes compared to placebo.
“Two hours after the treatment dose, more participants in the zavegepant group were pain-free than in the placebo group,” the researchers wrote.
They said the nasal spray was “effective in the acute treatment of migraines, with favorable tolerability and safety profiles,” adding that more studies are needed to determine “long-term safety and consistency of effect across attacks.”
“The results of this study show the potential of Zavegepant as an effective acute nasal spray for the treatment of migraine, a neurological disorder that affects more than one billion people worldwide,” said study leader Richard B. Lipton of the Albert Einstein College of Medicine in the US .
Pfizer reported that the most common side effects reported by those taking the nasal spray were an altered sense of taste in about one-fifth of the participants, nasal discomfort in 4 percent of those taking the drug, and nausea in 3.2 percent of those taking the drug .
“The intranasal formulation of Zavegepant represents a breakthrough innovation in patient-centric drug development,” said James Rusnak, Pfizer’s Chief Development Officer.
