Avanir Pharmaceuticals has published results from the Phase 3 TARGET study of its AVP-825 intranasal sumatriptan powder compared to placebo for the treatment of migraine. The article appears in the January 2015 issue of Headache. Earlier this year, the company announced positive results from the Phase 3 COMPASS study that compared AVP-825 to oral sumatriptan.
AVP-825 was initially developed by OptiNose and is delivered by OptiNose’s Breath Powered delivery device. Avanir acquired North American rights to the product in July 2013 and submitted an NDA in January 2014. The PDUFA goal date for the NDA is November 26, 2014.
The 230 participants in the study received either AVP-825 or a placebo device for self-administration when they had a migraine. At 30 minutes post-dose, 41.7% of patients using AVP-825 reported headache relief vs. 26.9% of those using the placebo device, and the difference remained statistically significant up to two hours post dose.
Avanir Chief Medical Officer Joao Siffert commented, “Some studies indicate that nearly half of the 37 million Americans suffering from migraines are dissatisfied with their current treatment. We believe AVP-825 could provide a targeted, fast acting migraine treatment option by combining low-dose sumatriptan, the most widely used prescription migraine medication, with an innovative delivery method. We are pleased to have the pivotal trial data published in a reputable medical journal and look forward to the upcoming FDA decision in November and to potentially being able to offer a new migraine treatment to patients in need.”
OptiNose President Ramy Mahmoud said, “From the beginning, we believed our innovative drug delivery approach would make it possible to significantly improve the clinical care of common diseases – and this study further supports that. We are pleased that the publication of these results, along with the results of the COMPASS trial, offers emerging evidence of this product’s efficacy alone and in comparison to the current ‘gold standard’ of migraine treatment.”
Read the Headache article.
Read the Avanir press release.
Read the OptiNose press release.
