CHICAGO, IL – September 20, 2008 – OptiNose today announced important results from a Phase II trial of its novel nasal drug delivery device with fluticasone for the treatment of chronic rhinosinusitis with nasal polyps. Patients experienced a significant reduction in polyp size and associated symptoms, with almost 80% reporting overall improvement. The data was presented at the annual meeting of the American Rhinologic Society.
Reduction in polyp size was measured using Lildholdt's Scale, a 4-point scale used to rate the size of nasal polyps. The proportion of subjects with a reduction in polyp score ≥1 on the Lildholdt's Scale was significantly higher compared to placebo at 4, 8 and 12 weeks, reaching 57.4% at the study's end vs. 9.1% for placebo. Patients also experienced significant improvements in sense of smell, nasal obstruction and nasal comfort.
"We are pleased with the effectiveness of our treatment for nasal polyps", said Per Djupesland, M.D., Ph.D., the study's co-author and Chief Scientific Officer at OptiNose AS. Dr. Djupesland also noted that the endpoints progressively improved as the patients advanced through the trial, whereas in many existing treatments the improvements eventually plateau within the same time period. "This raises the possibility that patients could see even greater improvements the longer they continue treatment."
This is the second Phase II trial OptiNose has conducted demonstrating the effectiveness of its novel device in delivering drugs to target sites throughout the nasal cavity. A previous study showed that OptiNose's novel device with sumatriptan was highly effective for the treatment of migraines.
OptiNose AS
OptiNose AS is a private Norwegian company. OptiNose has developed a series of nasal drug delivery devices for use with a number of topical, systemic and CNS compounds and with applications for both liquid and powder formulations. Two drug-device products have recently completed Phase II clinical trials. Both the delivery technology and products are available for licensing. Interested parties should contact Helena Djupesland, CEO, at +47 229 58017 to learn more.