OptiNose has announced that the COMPASS trial, a head-to-head comparison of the investigational treatment AVP-825 to sumatriptan tablets, currently the most widely used prescription medication for migraine, met the primary endpoint of greater reduction in migraine pain during the first 30 minutes after treatment.

AVP-825 is an investigational drug-device combination product consisting of a low dose of sumatriptan powder delivered intranasally using OptiNose's unique and patented new Bi-Directional Breath Powered technology platform. A New Drug Application (NDA) for AVP-825 was filed earlier this year, and the Prescription Drug User Fee Act (PDUFA) V goal date is November 26, 2014. The product was developed by OptiNose but will be commercialized and further developed in North America by Avanir Pharmaceuticals, a licensing partner.

"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," said Ramy Mahmoud, MD, MPH, President and Chief Operating Officer of OptiNose. "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."

The multicenter COMPASS study used a high quality double-blind, double-dummy, cross-over design to compare AVP-825 (22 mg) to the highest approved dose of oral sumatriptan (100 mg). The trial showed that with AVP-825 treatment, early reduction in pain was achieved in more headaches than with oral sumatriptan – the primary endpoint showed that during the first 30 minutes, headache pain intensity was statistically significantly lower with AVP-825 treatment (p<.0001). In addition, the trial achieved statistical significance for relevant secondary measures of Pain Relief and Pain Freedom as early as 15 minutes and at all of the following early time points measured (30, 45, 60, 90) before 120 minutes. In these topline data, several additional secondary endpoints also showed greater benefit with AVP-825 treatment.

The overall safety profile of AVP-825 was consistent with that observed in previous trials. Less than 2% of subjects experienced an adverse event leading to treatment discontinuation with use of either medication and there were no serious adverse events. Nasal discomfort and abnormal product taste were more common with AVP-825 administration; these adverse events were deemed mild in nearly 90% of cases.

OptiNose and Avanir will review the detailed data from the COMPASS study and plan to present the full results at an upcoming medical meeting.

Under the terms of the licensing agreement, OptiNose has granted rights to commercialization and future development of AVP-825 in North America to Avanir Pharmaceuticals in exchange for an upfront cash payment, certain shared development costs, and clinical, regulatory, and commercial milestone payments collectively valued up to $110 million. In addition, Avanir will make tiered royalty payments based on net sales in North America.

"The COMPASS trial is an important milestone for AVP-825 and for the OptiNose Bi-Directional Breath Powered delivery technology," said Peter Miller, Chief Executive Officer of OptiNose. "The results of this head-to-head trial reinforce the promise of our unique bi-directional technology platform and of our collaboration with Avanir to develop an innovative solution for patients suffering from the debilitating effects of migraine."