Breath‐Powered Intranasal Sumatriptan Dry Powder

A breath-powered delivery system for sumatriptan dry powder (brand name Onzetra Xsail, Alisa Viejo, CA, USA) is approved by the Food and Drug Administration (FDA) for the treatment of migraine attacks. Sumatriptan is the oldest of the triptan family. Available in the United States in tablet, liquid nasal, injectable, and skin patch forms. In general, triptan medications are taken at the onset of a migraine attack. As a group, they are a specific treatment that delivers relief by targeting the chemicals causing head pain, also treating the ill feelings that make migraines so uncomfortable. Each form of sumatriptan has its own benefit. Until now, for migraine patients who vomit with their headache attacks, or who need very rapid relief from pain, choices were limited to the inconvenient and painful pinch of the injectable formulation, liquid nasal sprays that mostly go down the throat, or the slower patch. The breath-powered device delivers 11 mg of sumatriptan dry powder into each nostril for a total dose of 22 mg. The device comes with two nosepieces per treatment (Fig. 1). First, a clear disposable nosepiece clicks into the reusable device. A white button on the device is pressed to pierce the capsule, releasing the drug into the nosepiece, which is then inserted into the nostril. The user blows forcefully into the mouthpiece, and the powder is delivered to the nasal tissue, blown high up into the nose. When one blows the powder, the back of the palate closes and prevents the powder from going down the throat. The advantage of this device over tablets is that the medicine is not absorbed through the stomach, whose function is often impaired during a migraine attack. Nasal absorption is fast and not affected by the nausea or gastrointestinal dysfunction typically present during a migraine attack. The closing of the palate when one blows the drug up the nose prevents the powder from being swallowed, which is a problem with liquid nasal sprays. Swallowing not only decreases how much sumatriptan gets in, but also the drug tastes bad, and this is reduced with the dry powder. A scientific comparison study was run to compare the sumatriptan breath–powered device with the traditional sumatriptan tablet. Migraine patients were assigned to a traditional, active sumatriptan tablet plus an inactive, sham, placebo device, or the active breath-powered device plus an inactive tablet (placebo). Of the 174 patients who completed the study, those who used the active breathpowered device had significantly greater pain relief than those who took the active tablet. This difference in favor of the device held at time points between 30 minutes and 2 hours following the treatment. After 2 hours, the degree of pain relief between the tablet and the breath-powered device merged and remained similar between 2 and 48 hours after the attack. This suggests that the device worked faster than the tablet for up to 2 hours.