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Last updated on April 19, 2014 at 13:20 EDT

Latest OptiNose US Inc. Stories

2014-01-30 08:32:21

AVP-825 uses novel Breath Powered(TM) drug delivery to treat migraine YARDLEY, Pa., Jan. 30, 2014 /PRNewswire/ -- A New Drug Application (NDA) was submitted on Monday January 27, 2014 to the U.S. Food and Drug Administration for AVP-825, a product using OptiNose's innovative closed-palate Breath Powered intranasal delivery system to deliver low-dose sumatriptan powder for the acute treatment of migraine. The NDA submission is based on a series of laboratory and clinical studies...

2013-07-02 16:23:38

New Drug Application (NDA) Filing Expected by Early 2014 ALISO VIEJO, Calif. and YARDLEY, Pa., July 2, 2013 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) and OptiNose AS today announced that the companies have entered into an exclusive North American license agreement for the development and commercialization of OptiNose's novel Breath Powered(TM) intranasal delivery system containing low-dose sumatriptan powder to treat acute migraine. If approved, this product would...

2013-06-28 12:23:59

BOSTON, June 28, 2013 /PRNewswire/ -- OptiNose US Inc. today announced that it will present data from three studies featuring its Breath Powered(TM) delivery technology at the 2013 International Headache Congress from June 27 to 30 in Boston. Among the data being presented are results from the pivotal phase III TARGET study, which compares the efficacy and safety of the OptiNose Breath Powered nasal delivery device containing a low dose of sumatriptan powder to placebo in patients...

2012-11-14 08:32:30

YARDLEY, Pa., Nov. 14, 2012 /PRNewswire/ -- OptiNose US Inc. today announced that the phase III TARGET study successfully met its primary endpoint, finding the new 16 mg OptiNose sumatriptan product provided headache relief for 68% of patients with moderate to severe migraines after two hours (p<0.01 compared to placebo). The TARGET study tested an innovative new product using OptiNose Bi-Directional(TM) nasal technology to deliver low-dose sumatriptan in a new way. The trial found...

2012-10-18 11:25:52

YARDLEY, Pa., Oct. 18, 2012 /PRNewswire/ -- OptiNose US Inc., today announced the publication of results from a study which showed that the proportion of the dose delivered to the blood vessel-rich middle and upper posterior regions in the back of the nose is three times higher with the OptiNose breath-powered Bi-Directional(TM) nasal delivery device than traditional liquid nasal spray. The study "Nasal Deposition and Clearance in Man: Comparison of a Bi-directional Powder Device and a...

2012-10-02 02:30:21

YARDLEY, Pa., Oct. 2, 2012 /PRNewswire/ -- OptiNose US Inc. today announced results of a study testing delivery of the migraine medicine sumatriptan with a novel device using OptiNose breath powered Bi-Directional(TM) nasal technology. In a direct comparison of drug absorption, the study found that OptiNose's sumatriptan product sent 62% more drug into the blood in the critical first 15 minutes than Imitrex(®) nasal spray (AUC (0-15) = 1.69 ng*hr/mL and 1.04 ng*hr/mL, respectively). The...