Yardley, PA – November 14, 2012 – OptiNose US Inc. today announced that the phase III TARGET study successfully met its primary endpoint, finding the new 16 mg OptiNose sumatriptan product provided headache relief for 68% of patients with moderate to severe migraines after two hours (p<0.01 compared to placebo). The TARGET study tested an innovative new product using OptiNose Bi-DirectionalTM nasal technology to deliver low-dose sumatriptan in a new way. The trial found patients began to experience headache relief as quickly as 15 minutes after administration, with nearly 42% reporting pain relief at 30 minutes post-treatment (p<.05 vs. placebo).
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“There are 30 million migraine sufferers in the US alone and many of these sufferers, despite current treatments, are dissatisfied and continue to search for new treatments that provide fast and effective migraine relief,” said Roger K. Cady, MD, Director of the Headache Care Center and Associate Executive Chairman of the National Headache Foundation. “This is the first migraine treatment to deliver medicine using a special new type of nasal device and also the first to use a powder form of sumatriptan. The treatment tested in this trial uses OptiNose technology to deliver a surprisingly low dose of a proven medicine in a unique new way. We found the treatment provided pain relief quickly and with few adverse events. Rapid relief can be very important in this condition where symptoms often come on fast and can be very debilitating.”
In this multicenter, double-blind, placebo-controlled study, migraine sufferers were randomized to self-administer either OptiNose sumatriptan or placebo using the OptiNose device when they had moderate to severe migraine pain. Pain scores were then assessed at various time points after administration. Pain was evaluated using a four point scale with headache relief defined as a reduction from moderate (grade 2) or severe (grade 3) pain to mild (grade 1) or complete relief (grade 0). The data show pain relief for some patients began as early as 15 minutes after treatment, and a statistically significant greater number of patients receiving OptiNose sumatriptan experienced headache relief compared to placebo at all times from 30 minutes through two hours. At two hours after taking the medication, 7 out of 10 patients taking OptiNose sumatriptan reported that they were experiencing meaningful relief from their headache pain.
Impact on Daily Living and Other Findings
A migraine attack has a substantial impact on a sufferer’s ability to go on with their daily activities. In this trial, OptiNose sumatriptan was found to have a significant positive impact on patients’ ability to perform daily activities. Clinical disability was assessed on a four point scale ranging from “no disability” (grade 0), to “bed rest may be necessary” (grade 3). By 45 minutes following treatment, patients taking OptiNose sumatriptan reported a statistically significantly lower clinical disability rating than those receiving placebo.
Patients in the study were also asked to respond to a preference questionnaire about their experience using the innovative OptiNose device. Of the 212 patients in the study, all of whom were newly introduced to the device in this trial, nearly 90% found the device to be very or somewhat easy to use and approximately 3 out of 4 found the device very or somewhat comfortable to use. There were no serious adverse events associated with OptiNose sumatriptan. There were also no systemic adverse events reported in more than a single subject, and local adverse events reported in the nose were generally mild and transient.
“At OptiNose we believe the strength of our delivery technology is the ability to transform existing medications and make them perform meaningfully better in order to meet real unmet patient needs,” said Peter Miller, Chief Executive Officer (CEO) of OptiNose. “The successful conclusion of our pivotal phase III study represents a significant step forward in realizing our goals for improving patient care with our new technology.”
Ongoing Clinical Program
OptiNose has launched a study to directly compare the efficacy and tolerability of OptiNose sumatriptan to sumatriptan tablets – the latter being the most widely used treatment for migraine today and the medicine in the well-known brand Imitrex®. The study, COMPASS, will assess the speed of headache relief and various other measures of efficacy and treatment related side-effects. The trial is currently enrolling. Click here or visit www.optinose.com for additional information.
About Bi-DirectionalTM Nasal Delivery Technology
OptiNose’s Bi-DirectionalTM nasal medication delivery technology significantly improves delivery to difficult-to-reach target sites deep in 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 nosepiece. Narrow nasal passages are gently 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 rather than into the throat or lungs.
OptiNose is a drug delivery company developing a breakthrough “Bi-DirectionalTM” nasal technology set to transform the static nasal drug delivery market. The company was founded in 2000 and reorganized with a US company launch in 2010. OptiNose devices are designed to reliably deliver intranasal medication (large molecule, small molecule, or vaccines) to target regions of the nasal cavity, including the sinus and olfactory regions, while preventing lung deposition. The simple devices are intended to unlock the potential for significant new benefits, including better local activity, better systemic bioavailability and pharmacodynamics, better immunogenicity, and for “nose-to-brain” delivery for treating neurologic and psychiatric disorders.
OptiNose offers both single and multi-use intranasal devices for delivering both liquid and powder formulations. The strongly patent-protected technology has been successfully tested in a number of clinical trials evaluating the advantages of the technology compared to traditional nasal sprays. OptiNose is actively developing internal products using the new technology, which is also available to license for delivery of proprietary medicines. Investors in OptiNose include Avista Capital Partners in New York, WFD Ventures LLC located in New York and Entrepreneurs Fund LP based in Jersey, Channel Islands. For more information please visit www.optinose.com.
Imitrex® (sumatriptan) is a registered trademark of GlaxoSmithKline.
SOURCE OptiNose US Inc.