FDA Approves Sumatriptan Nasal Spray for Acute Migraine

The FDA has approved sumatriptan nasal spray (Tosymra) for the acute treatment of migraine with or without aura in adults.

Anil Namboodiripad, PhD, president of Promius Pharma, said the nasal spray is formulated using a novel excipient called Intravail to achieve blood levels similar to a 4-mg sumatriptan subcutaneous injection, which results in rapid onset of action.

“For patients who suffer from the debilitating and disruptive effects of migraine, there continues to be a need for reliable and efficacious treatment options,” said Namboodiripad in a statement. “At Promius, we are committed to developing new ways of improving patient experiences. Tosymra is a mist-like spray that acts rapidly and is well tolerated.”

The most common side effects of the treatment are tingling, dizziness, feeling warm or hot, a burning sensation, feeling of heaviness, feeling of pressure, flushing, feeling of tightness, numbness, nasal reactions, abnormal taste, and throat irritation.

Promius warned that the nasal spray can cause serious side effects, including heart attack and other heart problems. Those taking the treatment are encouraged to stop using Tosymra and get emergency medical assistance if they have any symptoms of a heart attack, including nausea or vomiting, discomfort in the center of the chest, or severe tightness, pain, pressure, or heaviness in the chest, throat, neck, or jaw.

Other possible side effects include changes in color or sensation in the fingers and toes, problems with blood circulation in the legs and feet, increased blood pressure, serotonin syndrome, stomach and intestine problems, and seizures.

People with heart problems or a history of heart problems; narrowing of the blood vessels to the legs, arms, stomach, or kidney; uncontrolled high blood pressure; severe liver problems; or hemiplegic or basilar migraine should not use the spray.