October 23, 2006 – OptiNose is pleased to announce the completion of a Phase I study to evaluate the safety of fluticasone propionate delivered with OptiNose’s nasal drug delivery device for liquid formulations.
The study investigated the safety in 41 healthy volunteers of daily administrations of intranasal fluticasone propionate at doses of 400 and 800 μg per day over a seven day period. Parameters included intranasal tolerability, circulating cortisol levels, adverse events and fluticasone propionate pharmacokinetics.
The study concluded that fluticasone propionate administered intranasally once daily for seven days to healthy volunteers using the OptiNose device was well tolerated at doses of 400 μg and 800 μg with acceptable systemic exposure.
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. 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.