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OptiNose Reveals Bi-directional Nasal Device Phase II Results

PBR Staff Writer Published 11 August 2010

OptiNose, a provider of bi-directional nasal activity technology, has released positive Phase II trial results evaluating the bi-directional nasal device delivering fluticasone, a nasal steroid, which demonstrated to be effective in progressively reducing the size or eliminating nasal polyps in patients with chronic rhinosinustis (CRS) with nasal polyps.

OptiNose Phase II study results also showed that the drug delivery technology was equally effective in treating patients with newly diagnosed and those with recurring nasal polyps post sinus surgery.

OptiNose said that the clinical results achieved offered an opportunity for analysis for subgroups with different baseline polyp size.

Per Djupesland, chief scientific officer of OptiNose and inventor of the company's bi-directional delivery technology, said: "We are excited by study results that suggest our bi-directional drug delivery technology delivers a progressive treatment effect on nasal polyps of all sizes, leading to notable reduction and even complete resolution of polyps.

"Progressive reduction of all sized polyps is critical for successful treatment because large polyps become small polyps and then are eliminated. We were also pleased to see that our treatment is as efficient in the patients with recurring polyps following sinus surgery as in patients without prior surgery."

James Palmer, associate professor, director of the division of rhinology, department of otorhinolaryngology and head and neck surgery at the University of Pennsylvania, said: "These study results suggest greater efficacy in treating nasal polyps than existing methods and with further validation may be a means to avoid sinus surgery in certain cases."

Peter Miller, CEO of OptiNose, said: "We are encouraged by our findings across the Phase II clinical trials and particularly by the data represented in this subgroup analysis.

"We are now focusing on structuring a Phase III program towards conclusively demonstrating better efficacy of OptiNose's products for the treatment of both chronic rhinosinusitis with nasal polyps and for migraines."

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