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.