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).