BOSTON, MA - Saturday June 28, 2008 - OptiNose announced today that it presented important new data demonstrating the superior performance of its novel nasal drug delivery device with sumatriptan for the treatment of migraines. The Phase II results indicate that the drug-device combination achieves migraine relief as quickly and efficiently as injections without the discomfort, inconvenience and risk of needle-stick injuries. OptiNose presented the data at the Annual Scientific Meeting of the American Headache Society in Boston.
Headache relief was achieved in 74.3% and 83.8% of patients at 60 minutes and 120 minutes after administration, respectively, and 48.6% of patients remained pain free after 48 hours. The results were statistically significant when compared to the study's placebo group. The study also confirmed earlier Phase I results. In the Phase I study, the OptiNose powder nasal drug delivery device achieved the maximum sumatriptan concentration in the blood at a median time of 20 minutes after administration. This result was comparable to injections and much faster than other intranasal delivery technologies.
"We are excited to develop this new treatment for the approximately 30 million Americans who suffer from migraines," said Per Djupesland, M.D., Ph.D., the study's co-author and Chief Scientific Officer at OptiNose AS. "Our new device combination will offer patients a much-needed alternative to existing, slower-acting nasal inhalers and tablets and painful injections."
The user feedback from patients who participated in the study was also very encouraging. "The majority of the migraine patients found the device to be both comfortable and easy to use." said Dr Djupesland. "We believe that we can offer a unique therapy for migraine sufferers, combining fast relief, low side effects and high user compliance."
Unlike traditional nasal delivery devices, the unique design of the OptiNose device ensures that drug is delivered to target sites throughout the entire nasal cavity, achieving optimal dose delivery while avoiding the risk of drug deposition to the lungs.
OptiNose AS is a private Norwegian company. OptiNose has developed a series of nasal drug delivery devices for use with a number of topical, systemic and CNS compounds and with applications for both liquid and powder formulations. In addition, OptiNose has developed two drug-device products that have completed Phase II clinical trials. Both the delivery technology and products are available for licensing. Interested parties should contact Helena Djupesland, CEO, at +47 90 885 643 to learn more.