OptiNose, a leader in nasal drug delivery systems, is pleased to announce the publication in Cephalalgia of results from its Phase II clinical study investigating the efficacy and tolerability of its novel, intranasal drug/device product for the treatment of migraine.

Sumatriptan powder in 10mg and 20mg doses administered intranasally using OptiNose's bi-directional delivery device was highly effective in treating a single attack of moderate or severe migraine. The proportion of patients pain-free at two hours was 54% for the 10 mg dose, 57% for 20 mg and 25% for placebo (P< .05). These results compare very favorably with published figures of 26-42% for liquid sumatriptan nasal spray and 35.6% for zolmitriptan nasal spray and higher than the 28% /29% reported for oral triptans. In addition to high efficacy, OptiNose's bi-directional powder delivery eliminates drip-out and reduces the bitter taste associated with conventional nasal triptan products.

The proportion of subjects with relief of headache post-dose was significantly greater than placebo at 60 minutes (10 mg 73% vs. 38%, P< .01; 20 mg 74% vs. 38%, P< .01), 90 minutes (10 mg 78% vs. 41%, P< .01; 20 mg 77% vs. 41%, P< .01) and 120 minutes (10 mg 84% vs. 44%, P< .001; 20 mg 80% vs. 44%, P< .01). The onset of pain relief was much quicker than conventional orally and nasally delivered triptans and similar to subcutaneous injection of sumatriptan despite much lower systemic exposure. Sustained pain-freedom at 48 hours was also high for both doses (10 mg 47%, 20 mg 49%, P < .05). Treatment-related adverse events were rare.

"The World Health Organization places migraine amongst the top 20 of disabling disorders from a global perspective," says Fred Sheftell, M.D., founder and director of the New England Center for Headache in Stamford, CT. "Novel delivery systems that deliver rapid and sustained pain relief with minimal side effects are needed. The results of this study are encouraging and suggest that a novel formulation of an already established efficacious agent in the acute therapy of migraine via a novel and user friendly device could benefit many migraine patients."

"We are extremely encouraged by these results", says Dr. Per Djupesland, the study's co-author and CSO at OptiNose. "This study confirms that the superior deposition and rapid absorption of OptiNose's sumatriptan product offers both early and prolonged relief from pain without undesirable side effects. We are convinced that our treatment will provide unique advantages to patients with this debilitating disease."

About OptiNose Bi-directional Delivery Devices:
OptiNose's unique breath actuated devices deliver intranasal drugs to targeted regions in the nasal cavity, including the sinus openings and the olfactory region. This is achieved without any risk of lung deposition, unlike traditional nasal inhalers, nasal sprays or nebulizers. The Company offers both single and multi-use intranasal delivery devices for liquid and powder formulations. Core patents have been granted in Europe and the US. Variants of the basic delivery system are available for powder and liquid delivery. The technology has been successfully tested in a number of clinical trials to date including gamma scintigraphy studies to confirm highly superior deposition, studies evaluating the immune response to conventional antigens, trials showing excellent effects in chronic sinusitis with and without nasl polyps and studies evaluating the delivery of CNS active compounds. The results have confirmed the superiority of the technology compared to traditional nasal sprays.

About Migraine:
According to the American Headache Society, migraine is a disabling, episodic headache disorder associated with various combinations of neurologic, gastrointestinal, and autonomic symptoms that, affects approximately 28 million Americans, the majority of which are women. Common symptoms of migraine include recurrent headaches, nausea, vomiting, photophobia (sensitivity to light) and phonophobia (sensitivity to sound). Migraine costs the United States more than $20 billion annually in direct costs including doctor visits and medications and indirect costs such as missed work and reduced productivity.

Source:
Helena Djupesland
WFD Ventures