The first patients have been successfully enrolled in a phase III study involving the intranasal delivery of sumatriptan powder using the OptiNose bi-directional technology. The trial, named TARGET (AssessmenT of Delivery of Drug via A Novel Device to the IntRanasal Cavity for MiGraine PatiEnTs) will evaluate the safety and efficacy of this novel product – specifically assessing the ability to offer rapid pain relief, sustained freedom from pain and other measures. The OptiNose migraine product aims to be the first approved in the U.S. to administer powdered drug particles intranasally.
The TARGET study is a randomized, double-blind, placebo-controlled parallel group study of approximately 200 subjects (100 in each treatment group) across 15 sites in the U.S. The study will be comprised of both male and female subjects, 18-65 years of age with a diagnosis of acute migraine with or without aura.
The primary objective of the study is to evaluate headache relief at 120 minutes following a dose of 20 mg of sumatriptan delivered using the OptiNose device, compared with placebo, in the acute treatment of a single migraine attack.
“Conducting this study will allow us to evaluate the benefits of the novel OptiNose nasal powder device,” said Per G. Djupesland, M.D., Ph.D., Chief Scientific Officer (CSO) of OptiNose and inventor of the bi-directional delivery technology. “There is a significant unmet need among migraine patients for therapies that offer greater efficacy and faster onset of relief, and the OptiNose device holds the promise of providing an improved treatment option for these individuals.”
The American Migraine Study (AMS) II reported that 28 million people in the United States live with migraine. The overall prevalence was found to be 18.2% among females and 6.5% among males1. Half of the population in AMS II reported that the headaches were severe enough to affect their school and work productivity. Migraine headache leads to costs estimated to be $13 to $17 billion per year in the United States alone.2
About OptiNose Inc.
OptiNose is a drug delivery company with breakthrough bi-directional nasal technology set to transform the static nasal drug delivery market. Founded in 2000, OptiNose’s devices are designed to deliver intranasal drugs to target regions of the nasal cavity, including the sinuses and the olfactory region while preventing lung deposition. The company offers both single and multi-use intranasal delivery devices for liquid and powder formulations. The technology has been tested in a number of clinical trials assessing both clinical efficacy and safety.
About Bi-directional Nasal Delivery Technology
OptiNose’s bi-directional nasal delivery technology significantly improves delivery to targeted sites deep into the nose. A user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity completely. The natural exhaled breath then carries medication from the device into one side of the nose through a sealing nozzle. Narrow nasal passages are expanded and medication is carried well beyond the nasal valve to targeted sites. After delivering medication to the targeted sites, air painlessly flows in the opposite direction, exiting the nasal cavity through the other side of the nose.
1 Lipton RB (2010), Stewart WF, Diamond S, Diamond ML, Reed M. Prevalence and burden of migraine in the United States: Data from the American Migraine Study II. Headache 2010;41(7);646-657.
2 Goldberg LD (2005). The Cost of Migraine and Its Treatment. Am J Manag Care 2005;11: S62-S67.
Dan Zacchei, 212-446-1882