The US Food and Drug Administration has approved a world-first fast-acting nasal spray to treat migraines, pharmaceutical giant Pfizer announced on Friday.
Pfizer noted in a statement that it expects the drug named Zavzpret to be available in pharmacies in July 2023.
“The FDA approval of Zavzpretmarks a significant breakthrough for people with migraine who need freedom from pain and prefer alternative options to oral medications,” Angela Hwang, the pharmaceutical company’s chief commercial officer said in a statement.
Estimates suggest that over 40 million people in the US suffer from migraine and the World Health Organization classifies the condition as one of the 10 most disabling medical illnesses.
Migraines are characterised by debilitating attacks that can last four to 72 hours with symptoms such as pulsating headaches of moderate to severe pain intensity, sometimes along with nausea or vomiting.
Researchers have tested nasal sprays as an option to treat migraine in people for whom oral drugs are ineffective, slow-acting, or intolerable due to nausea and vomiting.
In a phase 3 clinical study, Pfizer found that Zavzpret – which represents a novel class of small molecule drugs – was superior to placebo in pain freedom from migraine at two hours post-dose.
The study, whose results were published recently in the journalThe Lancet Neurology, also found pain relief as early as 15 minutes versus placebo.
“Two hours after the treatment dose, more participants in the zavegepant group than in the placebo group had pain freedom,” scientists wrote.
They said the nasal spray “was efficacious in the acute treatment of migraine, with favourable tolerability and safety profiles,” while adding that further trials are needed to establish the “long-term safety and consistency of effect across attacks”.
“The results from this study demonstrate zavegepant’s potential as an effective acute nasal spray treatment for migraine, a neurological disorder that affects more than one billion people worldwide,” study lead author Richard B Lipton from the Albert Einstein College of Medicine in the US, said.
Pfizer reported that the most common side effects reported by those taking the nasal spray included an altered sense of taste in about a fifth of the participants, nasal discomfort in 4 per cent of the individuals, and nausea in 3.2 per cent of those taking the drug.
“The intranasal formulation for zavegepant embodies breakthrough innovation in patient-centric drug development,” Pfizer’s chief development officer James Rusnak said.
