Study Shows OptiNose Bi-Directional™ Nasal Technology Reaches Target Areas of the Nasal Cavity Much More Effectively Than Traditional Nasal Spray

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™ 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 Traditional Liquid Spray Pump," was published in the October 2012 issue of the Journal of Aerosol Medicine and Pulmonary Delivery.

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"Delivering medicine to targeted deep nasal regions has been widely recognized as a way to try and improve treatment of disease. There has been no method for simple, reliable delivery of medicine to those regions. Traditional nasal sprays are poor at consistently reaching those regions, with problems like 'drip out' and medicine swallowing. To solve this longstanding challenge, OptiNose has created an innovative new approach: breath-powered Bi-Directional™ technology," said Per G. Djupesland, M.D., Ph.D., Chief Scientific Officer of OptiNose and inventor of the Bi-Directional™ delivery technology. "This study shows that our novel delivery concept significantly improves the delivery of medicine to target sites in the middle and upper regions at the back of the nasal cavity. With this powerful new method of delivering drug, improved treatments for many disorders ranging from rhinosinusitis or migraine to brain diseases like Alzheimer's or autism may be possible."   

The study featured an open-label, crossover design where seven adult volunteers used both the OptiNose Bi-Directional™ nasal device and a traditional liquid nasal spray to deliver a radiolabeled dose into the nose. The radiolabeling allowed researchers to use an innovative gamma camera to create images showing where the radiolabeled powder and liquid were deposited within the nasal cavity. 

Study Results
The study found that the proportion of the dose delivered with the OptiNose technology to the middle and upper posterior regions of the nasal cavity was three times higher (53.5% vs. 15.7%, P<0.02) than the liquid spray. These regions of the nasal cavity are located in the back of the nose where a dense network of blood vessels facilitates faster drug absorption into the blood. In contrast, the traditional spray left a substantially higher proportion of the delivered dose on the floor of the nasal cavity (17.4% vs. 59.4%, P< 0.04), which often results in the medication being wiped off with a tissue or "sniffed" down the back of the throat and swallowed.

In addition, the powder delivery using the OptiNose technology resulted in faster overall clearance from the nose than the traditional spray. This was associated with less immediate loss of drug (e.g., to "drip out"), as indicated by the finding that two minutes after delivery there was greater total deposition in the nasal cavity with the OptiNose technology than with the liquid spray (98.3% vs. 85.8%, P<0.04). 

Nasal delivery could be very beneficial, especially for locally acting drugs to treat rhinitis and sinusitis, or as a way to improve the speed and extent of absorption of a medicine into the blood without an injection.  However, traditional nasal sprays tend to deposit a large portion of the medicine in the front regions of the nose, allowing the liquid to drip out, leading to a loss of medicine when it is wiped off with a tissue, or to be sniffed backwards along the nasal floor into the mouth and subsequently swallowed.

OptiNose Clinical Program
OptiNose recently completed the phase III TARGET study comparing sumatriptan powder (16 mg) versus placebo using OptiNose Bi-Directional™ nasal technology. Results will be available in the coming weeks. 

The COMPASS study is currently underway to compare OptiNose-delivered sumatriptan powder (16 mg) to the most widely prescribed migraine medication, sumatriptan tablets (100 mg).

About Bi-Directional™ Nasal Delivery Technology
OptiNose's Bi-Directional™ nasal medication delivery technology significantly improves delivery to difficult-to-reach target sites deep in the nose. A user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity completely. The natural exhaled breath then carries medication from the device into one side of the nose through a sealing nosepiece. Narrow nasal passages are gently expanded and medication is carried well beyond the nasal valve to targeted sites. After delivering medication to the targeted sites, air painlessly flows in the opposite direction, exiting the nasal cavity through the other side of the nose rather than into the throat or lungs.

About OptiNose
OptiNose is a drug delivery company developing a breakthrough "Bi-Directional™" nasal technology set to transform the static nasal drug delivery market. The company was founded in 2000 and reorganized with a US company launch in 2010. OptiNose devices are designed to reliably deliver intranasal medication (large molecule, small molecule, or vaccines) to target regions of the nasal cavity, including the sinus and olfactory regions, while preventing lung deposition. The simple devices are intended to unlock the potential for significant new benefits, including better local activity, better systemic bioavailability and pharmacodynamics, better immunogenicity, and for "nose-to-brain" delivery of medicines for neurologic and psychiatric disorders.

OptiNose offers both single and multi-use intranasal devices for delivering both liquid and powder formulations. The strongly patent-protected technology has been successfully tested in a number of clinical trials evaluating the advantages of the technology compared to traditional nasal sprays. OptiNose is actively developing internal products using the new technology, which is also available to license for delivery of proprietary medicines. 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.

SOURCE OptiNose US Inc.