YARDLEY, Pa., June 10, 2014 /PRNewswire/ -- OptiNose today 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."
About the COMPASS Trial
The COMPASS study was a multicenter, randomized, double-blind, double-dummy crossover, multi-attack study in which 275 migraine sufferers treated a total of 1,531 acute migraines with either the only dose of AVP-825 (22 mg) plus a placebo tablet or with a placebo delivered with an OptiNose Bi-Directional Breath Powered device plus a high dose (100 mg) sumatriptan tablet. Study participants had up to 12 weeks in each randomly assigned period to treat up to 5 migraine attacks. Headache pain intensity and other symptoms were assessed immediately before dosing and at 10, 15, 30, 45, 60, 90 and 120 minutes after administration, with 24 and 48 hour follow-up.
About OptiNose's Bi-Directional™ Breath Powered™ Delivery Technology
OptiNose's patented closed-palate Bi-Directional Breath Powered delivery technology is unique in that it uses the natural function of a user's breath to propel medications beyond the nasal valve into the deep, targeted areas of the nasal cavity more effectively and efficiently than current treatment approaches. A user exhales into the device, creating a naturally balanced closure of the soft palate and sealing off the nasal cavity completely. The exhaled breath carries medication from the device into one side of the nose through a specially shaped sealing nosepiece. Narrow nasal passages are gently expanded and medication is transported well beyond the nasal valve to targeted sites. After delivering medication to the targeted sites, air flows around to the opposite side of the nasal cavity and exits through the other side of the nose rather than into the throat or lungs.
AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder delivered intranasally utilizing closed-palate Bi-Directional Breath Powered delivery technology. If approved, AVP-825 would be the first and only fast-acting, dry powder intranasal form of sumatriptan for the treatment of migraine.
OptiNose is a Specialty Pharmaceutical Company built around a unique nasal delivery platform. The Bi-Directional Breath Powered device platform provides dramatically enhanced delivery of drug into the nasal cavity versus current treatments. When used to deliver select medications, the technology can enable value enhanced products with important new efficacy or safety characteristics. OptiNose has created single and multi-use devices for intranasal delivery of both liquid and powder drug formulations. The strongly patent-protected technology has been successfully tested in a number of clinical trials evaluating the advantages of this new technology. OptiNose is developing a pipeline of assets currently for the treatment of Central Nervous System disorders and Nasal Inflammatory Diseases. For more information, please visit www.optinose.com.
Investors in OptiNose include Avista Capital Partners in New York, WFD Ventures LLC located in New York and Entrepreneurs Fund LP based in Jersey, Channel Islands.