Onzetra Xsail Approved as Migraine Treatment


The FDA has approved sumatriptan nasal powder for the treatment of migraines with or without aura in adults.

The FDA has approved sumatriptan nasal powder (Onzetra Xsail) for the treatment of migraines with or without aura in adults.

Onzetra Xsail is the first breath-powered intranasal medication delivery system to treat migraines, according to Avanir Pharmaceuticals.

The nasal powder, formally known as AVP-825, comes in a 22 mg dose. It is delivered through the Xsail breath powered delivery device.

“Onzetra Xsail provides a new and much-needed treatment option for what can be a debilitating condition for millions of people,” said Roger Cady, director of the Headache Care Center and associate executive chairman of the National Headache Foundation, in a press release. “The Xsail breath powered delivery device allows the medication to be deposited deep into the nose, an area that is rich with blood vessels.”

The FDA’s approval was based on data from phase 2 and phase 3 trials, reference data on the use of sumatriptan, and safety data from more than 300 patients.

In the TARGET trial involving 230 patients who suffer from migraines, the participants were given either placebo or Onzetra to self-administer when they had moderate or severe migraine pain.

More patients who received Onzetra reported pain relief after 30 minutes than those in the placebo group.

The most common adverse effects were abnormal product taste, nasal discomfort, rhinorrhea, and rhinitis.

Related Videos
Laboratory test tubes and solution with stethoscope background | Image Credit: Shutter2U - stock.adobe.com
Image credit: Andrea Izzotti
Inflation Reduction Act is shown using the text and the US flag - Image credit: Andrii | stock.adobe.com
Pharmacy Interior | Image Credit: Tyler Olson - stock.adobe.com
Male pharmacist selling medications at drugstore to a senior woman customer | Image Credit: Zamrznuti tonovi - stock.adobe.com
Pharmacist assists senior woman in buying medicine in pharmacy - Image credit: Drazen | stock.adobe.com
Pharmacy, medicine and senior woman consulting pharmacist on prescription. Healthcare, shopping and elderly female in consultation with medical worker for medication box, pills or product in store - Image credit: C Daniels/peopleimages.com | stock.adobe.com
Image credit: fidaolga - stock.adobe.com
Pharmacists checking inventory at hospital pharmacy- Image credit: Jacob Lund | stock.adobe.com
Young male pharmacist giving prescription medications to senior female customer in a pharmacy | Image Credit: Zamrznuti tonovi - stock.adobe.com
© 2023 MJH Life Sciences

All rights reserved.