The US Food and Drug Administration (FDA) has approved a low-dose sumatriptan powder delivered intranasally (Onzetra Xsail, Avanir Pharmaceuticals) for the treatment of migraine with or without aura in adult patients, the company has announced.
The product (formerly called AVP-825) consists of 22 mg of sumatriptan powder delivered by using the novel Xsail breath-powered delivery device.
The FDA approval was based on data from phase 2 and phase 3 trials, safety data from more than 300 patients, and reference data from the extensive clinical use of sumatriptan over the past 20 years.
"Onzetra Xsail provides a new and much needed treatment option for what can be a debilitating condition for millions of people," said Roger K. Cady, MD, co-founder and director, Headache Care Center, Springfield, Missouri, and associate executive chairman, National Headache Foundation, in a press release from Avanir.
The system allows the medication to be deposited deep into the nose, an area rich with blood vessels, said Dr Cady. "By delivering the medication here, Onzetra Xsail provides targeted and efficient delivery with the potential for fast, consistent relief, while also limiting the amount of medicine that goes down the back of the throat."
Pain Relief
In the TARGET trial, 230 patients with migraine were randomly assigned to self-administer the sumatriptan powder or placebo using the Xsail delivery device when they had moderate to severe migraine pain. Pain was assessed at various time points after administration by using a four-point scale; headache relief was defined as a reduction from moderate (grade 2) or severe (grade 3) pain to mild (grade 1) or complete (grade 0) relief.
A significantly greater proportion of patients receiving the active treatment reported headache relief at 30 minutes (41.7% vs 26.9%; P = .03) and at every time point up to 2 hours compared with those using the placebo device (67.6% vs 45.2%; P = .002), the company reported.
In pooled studies, the treatment was well tolerated, with a low incidence of adverse events (AEs). The most common AEs were abnormal taste (20%), nasal discomfort (11%), rhinorrhea (5%), and rhinitis (2%). Local AEs were transient and mostly mild to moderate in severity.
The FDA initially declined approval AVP-825. In a 2014 Complete Response letter (CRL), the agency requested that Avanir assess the root cause or causes of device use errors observed in previously conducted human factors testing, Medscape Medical News reported at the time.
Human factors testing evaluates use-related risks and confirms that users can use the device safely and effectively, the company said in a statement. "A new human factors validation study will be required to assess usability of the device following improvements."
The company noted that the concerns raised by the FDA were "fully addressable" and that it would conduct a new human factors study, with input from the FDA.
The FDA did not find any clinical or nonclinical safety or efficacy issues, or any chemistry, manufacturing, and controls issues, the statement added. The agency also did not request that additional clinical trials be conducted before approval.
Breath-Activated
The system, now approved, is activated by a user's breath, the company explained in the recent press release. The user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity. Through a sealing nosepiece placed into the nostril, the exhaled breath carries medication from the device directly into one side of the nose.
As the medication is delivered, the air flows around to the opposite side of the nasal cavity and exits through the other nostril. Closure of the soft palate helps prevent swallowing and reduce gastrointestinal absorption.
Although many acute migraine treatment options are available, more than 70% of patients are not fully satisfied with their current migraine treatment, commented Stewart Tepper, MD, professor, neurology, Dartmouth Medical School, Hanover, New Hampshire, said in the release. "Given this high dissatisfaction, there remains an unmet need to provide patients with fast-acting, well tolerated therapies that deliver consistent relief."
The company expects to make the new product available in the coming months.
The product is not indicated for the prevention of migraine attacks. Its safety and effectiveness have not been established for the treatment of cluster headache.
The most widely used prescription migraine medication, sumatriptan has been available for over 20 years. It is contraindicated for patients with a history of coronary artery disease or coronary vasospasm.
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Cite this: FDA Okays Onzetra Xsail Intranasal Migraine Medication - Medscape - Jan 29, 2016.
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