Scientific Rationale for OPN-375
Nasal steroids are topical drugs, which means that like many skin treatments, they act on the spot where they are applied rather than being absorbed and circulated throughout the body. This helps make them safe, because they don’t have as much effect elsewhere in the body, but it also means that they must be delivered to the location where their effect is desired. In this case, to reduce nasal inflammation (and polyp size), nasal steroid treatments must reach the location of the inflammation (and the nasal polyps) in sufficient quantities. Reaching the front of the nose is not difficult, but current nasal drug delivery methods simply do not optimally reach the target sites beyond the nasal valve where polyps originate and where the sinuses drain. The OptiNose device, with its unique Bi-Directional™ Breath Powered™ mechanism of delivery, provides specific benefits over current nasal drug delivery systems, including improved delivery of topical medication to the sites where pathology of nasal polyps occurs.
OPN-375 Clinical Program
OPN-375 (a device using the OptiNose mechanism of action to deliver the topical steroid fluticasone) was studied in two Phase II trials exploring its use in chronic rhinosinusitis with nasal polyps and recalcitrant chronic rhinosinusitis (without nasal polyps). The encouraging results of these studies led to an improved version of the device and a global phase 3 clinical program for OPN-375. The phase 3 clinical trials included over 1,500 patients with chronic rhinosinusitis (with and without nasal polyps), have successfully been completed and OptiNose is poised to submit an NDA for nasal polyposis. Future development of OPN-375 includes phase 3 registration studies in patients with chronic rhinosinusitis without nasal polyps.