Microsoft word - optinose - crs rhinology journal release final - 10 19 10
New Data Show Therapeutic Benefits in Chronic Rhinosinusitis Patients Using Fluticasone
Delivered by OptiNose’s Novel Delivery Technology
-OptiNose announces publication of positive clinical results highlighting Company’s bi-directional drug
-Results further demonstrate efficacy potential of OptiNose technology across multiple conditions-
Yardley, PA – October 20, 2010
– Today OptiNose Inc. announced the positive results of a study
evaluating the efficacy of fluticasone when delivered by the Company’s novel bi-directional technology in
patients with refractory chronic rhinosinusitis (CRS). The results of the study have been published in an
article in the September issue of Rhinology.
The paper, entitled “Preliminary efficacy of fluticasone delivered by a novel device in recalcitrant chronic
rhinosinusitis,” is authored by rhinologists Fleur S. Hansen, M.D, Per G. Djupesland, M.D., Ph.D., Chief
Scientific Officer (CSO) of OptiNose and inventor of the Company’s bi-directional delivery technology, and
the principle investigator, Professor Wytske J. Fokkens, M.D., Ph.D., Chair of ENT Department at the
Academic Medical Centre, Amsterdam, The Netherlands. The results show administering fluticasone with
OptiNose’s device is effective in the treatment of refractory CRS, with significant and clinically relevant
improvements compared with placebo in both subjective and objective measures of the disease.
Chronic rhinosinusitis affects approximately 12 percent of Americans below the age of 45, causing both
physical symptoms and reduced quality of life. In Europe, between 7 and 27 percent of the urban
population has been reported to have CRS. While current medical therapies including oral steroids,
antibiotics and intranasal steroids may reduce inflammation and relieve symptoms, many patients and
healthcare providers remain unsatisfied with these options. Frustratingly, many recent trials with novel
topical and systemic treatment modalities have failed, leaving a substantial opportunity for improved
Professor Fokkens commented, “Chronic rhinosinusitis can be very debilitating and these results are
encouraging for patients suffering from this disease. There is a significant unmet medical need in CRS
given the limitations of current treatment options. This study demonstrates the importance of how
treatment delivery can be a key determinant of treatment success. OptiNose’s bi-directional technology
showed remarkably good results in patients with chronic rhinosinusitis who did not sufficiently respond to
standard medical treatment and repeated surgery.”
Highlights of the prospective, randomized, double-blind, placebo-controlled, parallel study of 20 adult
patients with longstanding refractory CRS to medical and surgical treatment include:
Endoscopy score for inflammatory mucosal swelling in the key region for sinus ventilation,
showed a significant and progressive improvement and normalization after 12 weeks treatment of the severely swollen mucosa.
After 12 weeks, there were significant improvements in the MRI scores in the OptiNose group as
compared to baseline and a positive trend as compared to placebo.
The nasal domain of the quality of life assessment (RSOM-31) was significantly improved with
OptiNose treatment as compared with placebo.
Nasal discomfort and combined scores were significantly improved during morning and evening
Sense of smell was improved with statistically significant scores versus placebo after 12 weeks.
Per G. Djupesland commented, “The results of this study provide preliminary evidence suggesting fluticasone coupled with OptiNose’s technology is an effective and well-tolerated treatment for patients with chronic rhinosinusitis. The key to OptiNose’s success is its ability to transport an effective anti-inflammatory medication to targeted areas beyond the nasal valve, including the middle meatus, which is
key for normal sinus ventilation, normal function of the nose and the sense of smell. These findings
corroborate the results of previous studies on patients with CRS and provide further evidence suggesting
that the OptiNose drug delivery technology may have a significant impact on patients across multiple
medical conditions.” About OptiNose Inc.
OptiNose is a drug delivery company with breakthrough bi-directional nasal technology set to transform
the static nasal drug delivery market. Founded in 2000, OptiNose’s devices are designed to deliver
intranasal drugs to target regions of the nasal cavity, including the sinuses and the olfactory region while
preventing lung deposition. The company offers both single and multi-use intranasal delivery devices for
liquid and powder formulations. The technology has been successfully tested in a number of clinical trials
with results confirming the superiority of the technology compared to traditional nasal sprays. 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. For more information please visit
www.OptiNose.com. About Bi-directional Nasal Delivery Technology
OptiNose’s bidirectional nasal delivery technology significantly improves delivery to the targeted sites
deep into the nose where the openings to the sinuses are located, which is considered essential to
achieving clinical effects in CRS with topical treatments. While exhaling into the device, the soft palate
automatically closes off the nasal cavity completely. The breath enters one nostril through a sealing
nozzle and triggers the release of drug particles into the airflow. This action causes the narrow nasal
passages to expand and carry these particles beyond the nasal valve to targeted sites. After delivering
drug particles to the targeted sites, the air flow then exits the nasal cavity through the other nasal
passage in the opposite direction.
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