OptiNose presents sumatriptan Phase II trial results at 2nd European Headache and Migraine Trust International

OptiNose Inc. announced the results from an analysis comparing the Phase II clinical trial obtained with its novel delivery technology to that of other formulations. The analysis suggests rapid absorption rate alone may not explain the efficacy in migraines treated with sumatriptan delivered with the Company's novel bi-directional technology. The results will be presented at the 2^nd European Headache and Migraine Trust International on 28^th of October 2010.

“It has been previously documented that OptiNose nasal powder device offers improved deposition in the nasal cavity of sumatriptan to segments innervated by the first and second trigeminal nerve branches”

The data highlight the technology's ability to offer the dual benefits for migraine sufferers of rapid onset of pain relief and sustained pain freedom. When comparing existing pharmacokinetic and pharmacodynamics data from various formulations of sumatriptan, it appears the rate of absorption alone does not explain differences in rates of headache relief.

"It has been previously documented that OptiNose nasal powder device offers improved deposition in the nasal cavity of sumatriptan to segments innervated by the first and second trigeminal nerve branches," said Per G. Djupesland, M.D., Ph.D., Chief Scientific Officer (CSO) of OptiNose and inventor of the Company's bi-directional delivery technology. "We speculate the significant clinical effects of OptiNose sumatriptan powder in migraine are in part due to blocking of pain signaling in the trigeminal nerve, widely considered to be a primary source of migraine pain."

The 2007 US Migraine Prevalence and Prevention study revealed the one-year prevalence is more than 17 percent for women and nearly six percent for men. In addition, according to the World Health Organization (WHO), migraine is in the top 20 causes of disability worldwide. This clinical trial assessed 117 adult patients with migraines of moderate or severe intensity. The patients were randomly allocated into three treatment groups: 10 mg sumatriptan, 20 mg sumatriptan or placebo. Highlights of the randomized, double-blind, placebo-controlled, dose-ranging, parallel group study include:

• A significantly greater proportion of subjects in both the 10 mg sumatriptan (54 percent) and 20 mg sumatriptan (57 percent) groups were pain-free at 120 minutes compared with placebo (25 percent).
• For both the 10 mg (73 percent) and 20 mg (74 percent) sumatriptan doses, the proportion of patients with relief of headache was significantly greater than placebo (38 percent) at 60 minutes.
• The median time to meaningful relief was 54 minutes for 10 mg sumatriptan and 50 minutes for 20 mg sumatriptan, with both times significantly faster than the median time of 120 minutes for placebo.
• There were marked reductions in the incidence of nausea, photophobia and phonophobia compared to baseline in both the 10 mg and 20 mg sumatriptan groups between 60 and 120 minutes post-dose.

"These results suggest the activity of sumatriptan can go beyond what is delivered traditionally via oral ingestion if the medication can be delivered to the right place and in the right amount," Djupesland said. "Further research is needed to explore the hypothesis that the improved delivery of medication with the OptiNose technology is blocking pain by direct actions on or via the trigeminal nerve, however these are certainly intriguing results."

OptiNose will be initiating a Phase III development program within the next year to further evaluate the efficacy and safety of sumatriptan delivered via its technology.