Avanir Pharmaceuticals and OptiNose have announced that a Phase 3b trial demonstrated that acute migraine patients experienced greater pain relief within 30 minutes of dosing using Avanir’s AVP-825 intranasal sumatriptan powder than patients taking sumatriptan 100mg tablets. In addition, a greater percentage of patients using AVP-825 were free of pain at 15 minute intervals up to 90 minutes post dosing compared to those using oral sumatriptan.
AVP-825 is delivered by OptiNose’s bi-directional breath powered delivery device; Avanir acquired North American rights to the product from OptiNose in July 2013 and submitted an NDA in January 2014.
Avanir Chief Medical Officer Joao Siffert commented, “AVP-825 was designed to deliver sumatriptan powder deep into the nasal cavity where is can be readily and efficiently absorbed. These data show that AVP-825, an investigational product, can efficiently deliver sumatriptan and confers faster migraine headache relief at a lower dose than the most commonly utilized sumatriptan tablets.”
OptiNose President and COO Ramy Mahmoud said, “We are very pleased with the results of the COMPASS Trial. These results further support the ability of our unique drug delivery technology to importantly improve disease treatment. A head-to-head trial with these impressive results also validates the skill and tireless effort of the people at OptiNose, who work every day on the research needed to develop truly meaningful new treatments to improve health and transform lives. If approved, we will all look forward to seeing patients suffering from migraine benefit from using AVP-825, the first of OptiNose’s new treatments.”
Read the Avanir press release.
Read the OptiNose press release.
