December 1, 2009: OptiNose is pleased to announce the publication of results from its Phase II clinical study investigating the efficacy and tolerability of its novel, intranasal drug/device product for the topical treatment of chronic rhinosinusitis with nasal polyps in Rhinology, the official journal of the International and European Rhinologic Societies.
Chronic rhinosinusitis with nasal polyps is a chronic disease that can significantly reduce a patient's quality of life, causing facial pressure and pain, nasal obstruction and reduced sense of smell. The novel OptiNose device delivers drugs to target sites deep in the nose, including the sinus openings where nasal polyps emerge. These targets are often difficult to reach with traditional nasal sprays.
In the Phase II study conducted by OptiNose, patients in the active treatment group experienced highly significant reductions in polyp size compared to placebo with corresponding significant and progressive improvements of all symptom scores including rhinitis symptoms, nasal discomfort and sense of smell. At the conclusion of the study, the polyps had disappeared in 10 out of 54 patients in the active group, whereas polyps were still present in all patients in the control group.
The multicenter, placebo-controlled study, conducted in 109 patients with mild-to-moderate bilateral nasal polyposis, assessed the efficacy, safety and tolerability of 400 micrograms of fluticasone propionate delivered twice daily with OptiNose's liquid nasal drug delivery device over a 12 week period. Reduction in polyp size was measured using Lildholdt's Scale, a 4-point scale used to rate the size of nasal polyps. A significantly greater percentage of subjects using the OptiNose product showed a reduction in polyp size greater than or equal to 1 on the Lildholdt's Scale when compared to placebo at 4, 8 and 12 weeks (22% vs 7%, p = 0.011; 43% vs 7%, p < 0.001; 57% vs 9%, p < 0.001). The summe
|Contact: Helena Djupesland|