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Sumatriptan is now available in a nasal powder form. We already have sumatriptan in a tablet, injection, nasal spray, and a skin patch. I mentioned this product over 5 years ago and finally it was just approved by the FDA. This does not mean it will be available right away as it often takes many months for the company to ramp up production. In some cases, such as with inhaled migraine drug Semprana (formerly called Levadex), it takes years before the manufacturer achieves FDA quality standards of production.

OptiNose is the company that developed Xsail Breath Powered Delivery Device which is used to deliver sumatriptan nasal powder. OptiNose licensed the product to Avanir Pharmaceuticals and they named it Onzetra. Onzetra is a fast-acting dry powder that is delivered into the nasal cavity. The patient exhales into the device, which seals the nasal cavity, and this carries the medication from the device directly into one side of the nose.

Nasal powder should be much more effective and more consistently effective than the nasal spray. The problem with the nasal spray is that the liquid tends to leak out of the nose or into the mouth, while the powder sticks to the nasal mucosa and all of it gets absorbed. And while the nasal spray contains 20 mg of sumatriptan and Onzetra only 11 mg, Onzetra should be more effective. Similarly, only 6 mg of injected sumatriptan is much more effective than 100 mg of sumatriptan in a tablet. But do we need another form of sumatriptan? Actually this may be a very good product for people who have a sudden onset of a severe migraine or those who vomit with their attacks. The injection works well for these patients, but many would rather avoid the pain of a shot. Zecuity, a new transdermal form of sumatriptan would seem to be a good choice, except for the fact that it works much slower than Onzentra.

The approval of Onzetra Xsal was based on the data from Phase 2 and 3 clinical trials, safety data from over 300 patients, and the historical data from various other formulations of sumatriptan, which have been on the market for over 20 years. One of the studies showed a significantly greater proportion of Onzetra Xsail patients reported headache relief at 30 minutes (42% vs. 27%) and at every time point up to 2 hours post-dose vs. placebo patients (68% vs. 45%).

Onzetra Xsail will be supplied as a disposable nosepiece containing a capsule and a reusable device. Each capsule contains 11 mg of sumatriptan and each kit contains 8 doses.

onzetratm-xsailtm-photo-1-5-HR

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The introduction of Levadex has been delayed again, this time for a year. It seems like deja vu all over again – I wrote the same thing on this blog in April of last year. Levadex, which the manufacturer (Allergan) just renamed as Semprana, is an inhaler containing DHE. DHE, or dihydroergotamine is one of the most effective injectable drugs for migraine. It should be even better in an inhaled form because it works faster and causes much less nausea than the injection. The FDA is again delaying the launch because of manufacturing problems. Apparently, the particle size of the drug when it comes out of the inhaler is not uniform enough. Many patients are unhappy, but I am sure that the Allergan is very unhappy too since they spent almost a billion dollars to acquire this drug from a small company that developed it.

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