OptiNose to Present Data Highlighting New Migraine Treatment at International Headache Congress

BOSTON, MA – June 28, 2013 – OptiNose US Inc. today announced that it will present data from three studies featuring its Breath Powered™ delivery technology at the 2013 International Headache Congress from June 27 to 30 in Boston. Among the data being presented are results from the pivotal phase III TARGET study, which compares the efficacy and safety of the OptiNose Breath Powered nasal delivery device containing a low dose of sumatriptan powder to placebo in patients with moderate to severe migraine headaches. All of the presentation abstracts will be published in Cephalalgia, the Journal of the International Headache Society.

“Various data we are presenting today will highlight how this novel delivery technology improves the delivery of medicine to hard-to-reach regions deep in the nasal cavity, how it can produce fast and efficient absorption of medicine into the blood, and how effective treatment with this technology can be,” said Ramy A. Mahmoud, M.D., M.P.H., Chief Operating Officer of OptiNose. “There are nearly 30 million migraine sufferers in the United States and many will be able to benefit from a new low-dose treatment that can rapidly provide effective pain relief with few adverse events.”

The company is also taking advantage of the novel OptiNose technology to develop products delivering other medications, each intended to transform the ability of already safe and effective medications to treat disease in a meaningfully better or safer way.

Abstracts of Interest

1) Results from the phase III TARGET study, a single-dose, multicenter, randomized, double-blind, placebo-controlled, parallel-group study comparing the efficacy and safety of OptiNose Breath Powered technology delivering low-dose sumatriptan powder versus placebo in the treatment of patients with moderate to severe migraine headaches.

  • Efficacy and Safety of a Novel Breath Powered Powder Sumatriptan Intranasal Treatment for Acute Migraine
    Abstract No. 450079, poster presentation, Friday, June 28, 2013 at 10:30am – 12:00pm

2) Data from a randomized, single-dose, four-way cross-over study assessing the absorption into the blood of sumatriptan intranasal powder administered using the Breath Powered OptiNose drug delivery device compared to Imitrex® subcutaneous injection, Imitrex nasal spray and Imitrex oral tablets in healthy adult volunteers.

  • Randomized Comparison of the Pharmacokinetics of Sumatriptan Powder Delivered with the OptiNose Breath Powered Intranasal Device to Imitrex Nasal Spray, Tablet, and Injection
    Abstract No. 450319, poster presentation, Friday, June 28, 2013 at 10:30am – 12:00pm

3) A review of evidence for human in vivo drug deposition patterns in different regions of the nose with devices intended to provide reliable and efficient drug delivery to upper/posterior nerve structures deep in the nasal cavity.

  • Comparison of Methods for Delivering Drug to Regions of Deep Intranasal Nerve Structures: Review of Human Data
    Abstract No. 450593, poster presentation, Friday, June 28, 2013 at 10:30am – 12:00pm

About OptiNose Breath Powered™ Delivery Technology

OptiNose’s Breath Powered delivery (BPD) technology is unique in that it uses the natural function of a user’s breath to propel medications beyond the nasal valve into the deep, targeted areas of the nasal cavity more effectively, efficiently and consistently than current treatment approaches. A user exhales into the device, creating a naturally balanced closure of the soft palate and sealing off the nasal cavity completely. The exhaled breath carries medication from the device into one side of the nose through a sealing nosepiece. Narrow nasal passages are gently expanded and medication is transported well beyond the nasal valve to targeted sites. After delivering medication to the targeted sites, air painlessly flows around to the opposite side of the nasal cavity and exits through the other side of the nose rather than into the throat or lungs. For more information about Breath Powered delivery technology and its capabilities, please click on the link below.

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About OptiNose

OptiNose is a drug delivery company developing a breakthrough Breath Powered nasal technology set to transform the static nasal drug delivery market. OptiNose devices are designed to reliably deliver nasal medication 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 and for “nose-to-brain” delivery for treating neurologic and psychiatric disorders.

OptiNose has created single and multi-use nasal 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.

David Barton