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Avanir Gains - AVP-825 Hits Phase III Primary Endpoint - Analyst Blog

Avanir Pharmaceuticals, Inc. 's ( AVNR ) shares gained 2.4% following the company's announcement that AVP-825 has met the primary and secondary endpoints in a phase III study. Shares increased an additional 3.5% in the following trading session.

The multi-center, randomized, double-blind, double-dummy crossover phase III study (COMPASS) was conducted to compare avanir's AVP-825 (22 mg) to sumatriptan (100 mg) for the treatment of acute migraine in adults. AVP-825 was well-tolerated in patients.

AVP-825 met the primary efficacy endpoint which showed that patients suffering from migraine achieved better pain relief within 30 minutes of treatment with AVP-825 when compared to sumatriptan tablets. Additionally, patients reported freedom from pain during a greater proportion of migraine attacks at 15, 30, 45, 60 and 90 minutes after dosing with AVP-825 compared to patients treated with sumatriptan tablet.

According to the American Migraine Foundation, nearly 12% (approximately 36 million people) of the U.S. population suffers from migraine headaches.

Johnson and Johnson 's ( JNJ ) Topamax is approved for the treatment of migraine.

Avanir's AVP-825 is under review in the U.S. for the treatment of acute migraine in adults. A response from the FDA should be out by Nov 26. Approval would make AVP-825 the first and only fast-acting dry-powder nasal delivery form of sumatriptan. On approval, Avanir intends to launch AVP-825 in the first half of 2015.

Avanir carries a Zacks Rank #2 (Buy). Some better-ranked stocks in the health care sector include Gilead Sciences Inc. ( GILD ) and ANI Pharmaceuticals, Inc. ( ANIP ). Gilead and ANI Pharmaceuticals hold 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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