First patient enrolled in head-to-head efficacy trial comparing OptiNose sumatriptan drug delivery to sumatriptan tablets
Yardley, PA – October 2, 2012 – OptiNose US Inc. today announced results of a study testing delivery of the migraine medicine sumatriptan with a novel device using OptiNose breath powered Bi-Directional™ nasal technology. In a direct comparison of drug absorption, the study found that OptiNose’s sumatriptan product sent 62% more drug into the blood in the critical first 15 minutes than Imitrex® nasal spray (AUC 0-15 = 1.69 ng*hr/mL and 1.04 ng*hr/mL, respectively). The OptiNose technology achieved this improved effect despite delivering 20% less drug into the nose (16mg) than the Imitrex liquid nasal spray (20mg).
In addition to showing better early drug absorption than Imitrex nasal spray, the study demonstrated in healthy volunteers that a 16mg dose of OptiNose sumatriptan – 84% less drug than Imitrex® 100 mg tablet – delivered three times more drug into the blood within the first 15 minutes than the oral tablet. During migraine attacks there is a delay in stomach emptying which slows and reduces the reliability of absorption of sumatriptan pills even more, a problem avoided by effective administration of drug in the nose.
“Migraines affect nearly 30 million Americans. People often experience symptoms that progress rapidly, making it difficult to initiate or complete daily activities. Even with the wide range of current medications, many migraine sufferers are dissatisfied and searching for new treatments that provide faster relief with fewer side effects,” said Ramy A. Mahmoud, M.D., M.P.H., Chief Operating Officer of OptiNose. “These data show the OptiNose technology has the capability of more efficiently and effectively delivering medicine into the blood in the important first 15 to 30 minutes. Now that OptiNose has demonstrated better drug delivery, we are working on the clinical program to show how improved drug delivery translates into meaningful benefits for migraine sufferers.”
To assess the clinical relevance of these study findings, OptiNose has already begun enrolling patients in a head-to-head study comparing OptiNose nasal sumatriptan powder (16 mg) to the most widely prescribed headache medicine, sumatriptan tablets (100 mg) – the medicine in Imitrex. The study, called the COMPASS trial, will assess early headache relief (15 and 30 minutes after the first dose of medicine), as well as headache relief at other time points 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.
Additional Study Information
This randomized, single-dose, four-way cross-over study assessed the pharmacokinetic (PK) profile of sumatriptan intranasal powder (16 mg) administered using the breath powered OptiNose Bi-Directional™ drug delivery device compared to Imitrex® subcutaneous injection (6 mg), nasal spray (20 mg) and oral tablets (100 mg) in 20 healthy adult volunteers. Standard PK assessments including peak plasma concentration, drug exposure over time and total drug exposure were measured.
In addition to the above results, the study found patients taking 16mg sumatriptan with OptiNose technology had substantially less total exposure to drug than those given a standard dose of Imitrex 100 mg oral tablet. Total drug exposure for Imitrex tablets was more than four times higher than with OptiNose nasal powder delivery. Total serum exposure was similar between 16mg delivered with an OptiNose Bi-Directional™ device and and 20mg Imitrex nasal spray, though absorption was notably faster with OptiNose. Total drug exposure was twice as high with Imitrex injection, a treatment option generally associated with a notably different side-effect profile.
There were no serious adverse events (SAEs) or discontinuations due to adverse events (AEs). The most commonly reported adverse events were mild nausea (3 reports each following Imitrex injection and tablets) and mild flushing (4 reports following Imitrex injection).
Phase III TARGET Study
A phase III trial called the TARGET study was initiated in January to prove the efficacy and safety of OptiNose delivery of low-dose sumatriptan. Results will be available later this month, specifically assessing the ability of OptiNose sumatriptan delivered with breath powered Bi-Directional™ technology to offer rapid pain relief, meaningful headache relief and other measures.
About Bi-Directional™ Nasal Delivery Technology
OptiNose’s Bi-Directional™ 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-Directional™” 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 of medicines for 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) tablets, Imitrex® (sumatriptan) injection and Imitrex® (sumatriptan) nasal spray are registered trademarks of GlaxoSmithKline.