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news.Avanir Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has issued preliminary written feedback to its New Drug Application (NDA) for AVP-825.
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AVP-825 is a drug-device combination product consisting of low-dose sumatriptan powder, delivered intranasally utilizing a novel Breath Powered delivery technology.
The FDA has raised questions regarding the human factor validation study data submitted as part of the NDA. Human factor testing focuses on the interactions between people and devices. The goal of human factor testing is to evaluate use-related risks and confirm that users can use the device safely and effectively. Although the NDA review is ongoing, Avanir has concluded, at this time, that approval of AVP-825 may be unlikely by the PDUFA date of November, 26, 2014.
The FDA feedback was provided via a Discipline Review letter, which is a standard vehicle to convey early thoughts on possible deficiencies of an application. In the letter, the FDA requested that the company optimize the product-user interface and conduct additional human factor testing.
In addition, the FDA commented that the NDA review is not complete and that they may have additional comments regarding the application.
"We are currently reviewing the correspondence from the FDA and are awaiting the final feedback when the full NDA review cycle is complete on November 26th," said Joao Siffert, MD, chief medical officer of Avanir.
"We plan to work closely with the FDA to answer the agency’s questions and satisfy their requirements. We remain confident that AVP-825 will be an important new treatment option for migraine patients who are in need of alternative, fast acting and well tolerated medications."
AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder (22mg) delivered intranasally utilizing a novel Breath Powered delivery technology.
If approved, AVP-825 would be the first and only fast-acting, dry-powder intranasal form of sumatriptan for the treatment of migraine. AVP-825 is an investigational drug-device combination product not approved by the FDA.
Sumatriptan is the most commonly prescribed migraine medication. Sumatriptan is contraindicated for certain patients, including those with a history of coronary artery disease (CAD) or coronary vasospasm.
The Breath Powered delivery technology is activated by user’s breath to propel medications deep into the nasal cavity where absorption is more efficient and consistent. 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. Narrow nasal passages are gently expanded and medication is dispersed deep into the nasal cavity reaching areas where it can be rapidly absorbed. 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 or inhalation of sumatriptan powder into the lungs.