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Avanir's Migraine Drug Gets Complete Response Letter - Analyst Blog

Avanir Pharmaceuticals, Inc. ( AVNR ) faced a regulatory setback with the FDA issuing a complete response letter (CRL) for its new drug application for AVP-825. However, the agency's decision did not come as a surprise since in a preliminary feedback earlier this month, the FDA had asked Avanir to conduct additional human factor testing on AVP-825. Avanir is looking to get AVP-825, a drug-device combination product consisting of low-dose sumatriptan powder delivered intranasally utilizing a novel Breath Powered delivery technology, approved for the treatment of migraine.

In the CRL, the FDA has asked Avanir to evaluate the primary reasons that led to erroneous use of the device as was observed in the human factors testing conducted earlier. Additionally, the agency stated that Avanir should conduct a new human factors validation study to evaluate the usability of the device following improvements.

Importantly, the company confirmed that the FDA did not bring up any safety or efficacy issues regarding AVP-825. This was a relief for Avanir since the company will not have to conduct additional studies on the candidate in order to get it approved.

Avanir said that it is working with the FDA towards implementing the necessary changes. The company intends to conduct a fresh human factors study and expects to respond to the CRL in the first half of 2015.

Our Take

We are disappointed with the delay in AVP-825's approval. This is because approval for the candidate would have boosted the company's portfolio, which currently comprises Nuedexta only. Moreover, AVP-825 would have been the first and only fast-acting, dry-powder intranasal form of GlaxoSmithKline's ( GSK ) Imitrex (sumatriptan) for the treatment of migraine.

Meanwhile, we expect investor focus to remain on pipeline updates from the company. Currently, Avanir is developing AVP-923 for the treatment of levodopa-induced dyskinesia in Parkinson's disease with proof-of-concept data expected by year end.

Avanir currently carries a Zacks Rank #2 (Buy). Some better-ranked stocks in the biotech sector are Biogen Idec Inc. ( BIIB ) and Cytokinetics, Inc. ( CYTK ). Both carry a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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