US FDA okays fast-acting nasal spray for migraines

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New York, March 11 (IANS) The US Food and Drug Administration (FDA) has approved a fast-acting nasal spray for treatment of migraines developed by Pfizer, the company said.

In clinical trial results, published in the journal Lancet Neurology, the treatment — called zavegepant and will be sold as Zavzpret — demonstrated pain relief as early as 15 minutes.

Participants in the trial who took the medication were more likely to report returning to normal function 30 minutes to two hours after taking it.

In a study of 1,269 patients — half on Zavzpret and half on a placebo — 24 per cent on the medication reported freedom from pain, compared to about 15 per cent who took a placebo.

The nasal spray also 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.

“The FDA approval of Zavzpret marks a significant breakthrough for people with migraine who need freedom from pain and prefer alternative options to oral medications,” said Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceuticals Business, Pfizer, in a statement.

Pfizer said that Zavzpret is “anticipated to be available in pharmacies in July” this year, but did not disclose the price.

Migraine is characterised by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity often associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia).

The World Health Organisation classifies migraine as the second leading cause of disability in the world.

According to Pfizer, Zavzpret is the first and only nasal spray for migraines which uses a migraine inhibitor that attempts to block the release of proteins called calcitonin gene-related peptides. Studies have shown that these peptides are present in greater volume during an attack causing inflammation and pain.

The Zavzpret study also showed improvement in most bothersome symptoms two hours after taking the medicine — 40 per cent versus 31 per cent for those on a placebo.

The trial participants also reported some side effects. About one-fifth of those who took the medication reported an altered sense of taste. Others experienced nasal discomfort and nausea.



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