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news.The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Avanir Pharmaceuticals' new drug application (NDA) for AVP-825, an investigational drug-device combination product.
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AVP-825 consists of low-dose sumatriptan powder delivered intranasally using a new Breath Powered delivery technology, for the treatment of migraine
This delivery technology is activated by a user’s breath to propel medications deep into the nasal cavity where absorption is more efficient and consistent.
In the CRL, the FDA requested Avanir to assess the root causes of device use errors observed in the previously conducted human factors testing.
Main aim of the human factors testing is to evaluate use-related risks and confirm that users can use the device safely and effectively.
The company said that a new human factors validation trial will be necessary to evaluate usability of the device following improvements.
The FDA did not find any clinical or non-clinical safety or efficacy issues nor chemistry, manufacturing and controls (CMC) issues.
In the letter, the FDA did not request to conduct any additional clinical trials prior to the approval.
Avanir chief medical officer Joao Siffert said: "We believe the concerns raised by the FDA are fully addressable.
"Following the receipt of the preliminary feedback we have been working internally and with the FDA toward implementing changes prior to repeating the human factors study.
"Based on these conversations, we will conduct a new human factors study, with input from the FDA, with a goal to respond to the CRL in the first half of calendar 2015."
If approved by the FDA, AVP-825 will be the first and only fast-acting, dry-powder intranasal form of sumatriptan for the treatment of migraine.