YARDLEY, Pa.--(BUSINESS WIRE)--OptiNose today announced that the TARGET study – a pivotal phase III study evaluating the efﬁcacy and safety of AVP-825, will be published in the January 2015 issue of Headache, The Journal of Head and Face Pain, the official journal of the American Headache Society (Early access is now available). AVP-825 is an investigational drug-device combination product developed by OptiNose which uses OptiNose’s patented Bi-DirectionalTM Breath PoweredTM technology to deliver a low dose of sumatriptan powder into the nose. A New Drug Application (NDA) for AVP-825 has been accepted by the FDA, and the Prescription Drug User Fee Act (PDUFA) goal date is November 26, 2014. AVP-825 was developed by OptiNose and has been licensed to Avanir Pharmaceuticals for commercialization in North America.
“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,” said Ramy Mahmoud, MD, MPH, President of OptiNose.
Mahmoud added, “We are also excited about the potential to truly transform care for the large population of dissatisfied patients suffering from chronic nasal diseases with our next product, OPN-375, which is in development worldwide. Ultimately, these products, and others to come focused on additional disease states, have the potential to bring new levels of relief to millions of patients worldwide.”
The TARGET study data demonstrated that AVP-825 provided relief of moderate or severe migraine headache in adults. Headache relief became evident as early as 15 minutes after treatment in some patients (19.4% AVP-825 vs. 14.4% placebo device), reaching statistical significance at 30 minutes (41.7% vs. 26.9%, P=0.03). A significantly greater proportion of AVP-825 patients also reported headache relief at 2 hours post-dose (68% vs. 45%, P=0.002), and relief was sustained through 24 and 48 hours in a greater proportion of patients who received AVP-825 vs. placebo. The treatment was well tolerated, with the most common AEs being product taste (22%), nasal discomfort (13%), rhinorrhea (5%), and rhinitis (3%); local AEs were mostly mild to moderate in severity and transient.
About the TARGET Trial
In this multicenter, double-blind, placebo-controlled study, 212 migraine sufferers were randomized to self-administer either AVP-825 or placebo using the Breath Powered device when they had moderate to severe migraine pain. Pain scores were then assessed at various time points after administration. Pain was evaluated using a four point scale with headache relief defined as a reduction from moderate (grade 2) or severe (grade 3) pain to mild (grade 1) or complete relief (grade 0).
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 natural 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, balancing the pressure on the soft palate. 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 OptiNose’s 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. AVP-825 is an investigational drug-device combination product not approved by the FDA.
OPN-375 is an investigational product that uses the patented OptiNose technology to deliver a well-understood topical steroid medication (fluticasone) into the nasal cavity in a deeply distributed manner different from any other treatment. Available data, including two published Phase II trials, suggest that OPN-375 has potential to be a breakthrough that creates a transformational level of efficacy for the treatment of serious chronic nasal inflammatory diseases like chronic rhinosinusitis with nasal polyps. A global late-phase clinical program for OPN-375 enrolling over 1500 patients is underway.
OptiNose is a Specialty Pharmaceutical Company built around a unique nasal delivery technology platform. The Bi-Directional Breath Powered device platform provides dramatically enhanced delivery of drug into the nasal cavity compared to current treatments. When used to deliver select medications, the technology may 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.