DEVELOPMENT OF NEXT GENERATION BREATH-ACTUATED BI-DIRECTIONAL MULTI-DOSE NASAL DELIVERY DEVICE
21 December 2005 - Cambridge Consultants

OptiNose AS, the leading Norwegian drug delivery company and Cambridge Consultants are developing the next generation breath-actuated bi-directional multi-dose nasal delivery device, a move that is set to revolutionise the treatment of rhinosinusitis, as well as Parkinson's disease, sexual dysfunction and other conditions.

Cambridge Consultants has used its considerable experience in developing liquid drug delivery systems to create a multi-dose bi-directional nasal delivery device for OptiNose. The design concept is based upon OptiNose's existing nasal delivery technology, which is unparalleled in its ability to effectively deliver drugs to sites within the nose which standard nasal sprays are unable to access, whilst uniquely preventing drug deposition in the lung.

Cambridge Consultants has now finalised the design of the multi-dose liquid device, which is targeted to enter clinical trials during 2006, with the capability to carry up to 120 doses in a single device.

The potential market for the treatment of rhinosinusitis is growing rapidly. Recent estimates suggest that 37 million people suffer with rhinosinusitis in America and a similar number in Europe, making it one of the most common chronic illnesses. Parkinson's disease affects almost 4 million people worldwide, with 2% of the population developing the disease at some point during life. Erectile dysfunction is an increasingly common condition in ageing men, especially those with conditions such as diabetes, hypertension, depression and high blood pressure. The global male sexual dysfunction market is estimated to grow from $2.3 billion in 2004 to more that $5 billion by the end of 2009.

The treatment of rhinosinusitis is poorly resolved by current nasal delivery systems because the drug does not adequately reach the upper posterior of the nasal passage. The new device, currently under development, exploits the body's natural reflex that isolates the nasal circuit from the lungs during exhalation against a resistance. As the patient breathes into the device, the exhaled air actuates the delivery device, the airflow created by exhalation then carries the spray droplets into the nose and into the posterior nasal passage beyond the nasal valve, allowing deposition of active substance in the region of the sinus. At the same time the process of breathing-out automatically closes the nasal cavity, removing the risk of distribution to the lungs.

A pilot study has shown that OptiNose's technology achieves better deposition to the middle meatus where the entrance to the sinuses are located and from which nasal polyps originate. Delivery of drug to this area is a pre-requisite for success in treating rhinosinusitis.

Helena Kyttari Djupesland, CEO of OptiNose commented, "By working with Cambridge Consultants on this bi-directional multi-dose liquid device we have been able to combine leading technology with excellent design and development capability. We are now in the process of creating a truly revolutionary product."

She added, "Given the inadequacies with the current technologies, we are committed to offering an effective solution for people suffering from conditions such as rhinosinusitis. Our aim is to provide them with an effective, portable, convenient and safe alternative."

OptiNose's technology can also target the olfactory bulb region from where drugs are reported to be able to readily pass into the cerebrospinal fluid.

http://www.cambridgeconsultants.com/

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