Onzetra Xsail, which is an intranasal delivery device for sumatriptan, received FDA approval last week. Sumatriptan is the active ingredient of Imitrex. The FDA approval is not for the drug, per se—sumatriptan has been in use for two decades—but for a new delivery method for the drug.

Onzetra Xsail isn't exactly an inhaler (you actually exhale into it), but the medication goes into your nose, like an inhaler or nasal spray. "Breath-activated" is the terminology the manufacturer uses. The device has both a nosepiece and a mouthpiece. To take the medication, insert the nosepiece into one nostril and put your mouth around the mouthpiece, then exhale through your mouth. Exhaling closes off your soft palate and seals your nasal cavity, then the device carries the medication directly into your nostril.

This delivery method's advantage is that it gets medication into your system more quickly thank pills, so the triptan can get to work on your migraine even faster. Injections also deliver medication quickly, but they have the downfall of being, well, injections. Unlike traditional nasal sprays, Onzetra Xsail is a powder, which means it won’t drip down your throat.

Onzetra Xsail contains 22 mg of sumatriptan. In pill-form, the most efficacious dose of sumatriptan is 100 mg. In a study comparing the two delivery methods, the biggest difference was seen within the first 30 minutes of treatment. The 22 mg of powder in Onzetra Xsail provided greater rates of pain relief and pain freedom within the first 15 minutes of use. It also provided a greater reduction of pain intensity over the first 30 minutes after treatment. Rates of relief over 24-48 hours were similar, even though the powder was a much lower dose.

Sumatriptan is the most prescribed triptan, largely because it is the oldest and least expensive. Even though sumatriptan is available as a generic, Onzetra Xsail is brand name, so it will cost more. As a comparison, I checked GoodRx drug prices for similar drugs. The recently approved transdermal sumatriptan patch called Zecuity costs $300 per dose without insurance. Brand name Imitrex in a standard nasal spray costs approximately $75 a dose without insurance; the generic nasal spray is about $35 a dose.

The product should be available in coming months. Like every sumatriptan product, it is not for people who have a history of coronary artery disease or coronary vasospasm. 

REFERENCES

Avanir Pharmaceuticals (Jan. 28, 2016). Avanir Pharmaceuticals Announces FDA Approval of Onzetra™ Xsail™ (AVP-825) for the Acute Treatment of Migraine in Adults. Press release. Retrieved Feb. 2, 2016 from http://www.multivu.com/players/English/7266957-ava...

Tepper, S. J., Cady, R. K., Silberstein, S., Messina, J., Mahmoud, R. A., Djupesland, P. G., ... & Siffert, J. (2015). AVP‐825 Breath‐Powered Intranasal Delivery System Containing 22 mg Sumatriptan Powder vs 100 mg Oral Sumatriptan in the Acute Treatment of Migraines (The COMPASS Study): A Comparative Randomized Clinical Trial Across Multiple Attacks.Headache: The Journal of Head and Face Pain, 55(5), 621-635.