OptiNose has announced Phase 3 results from a study of its sumatriptan nasal powder for the treatment of migraine, as well as a grant from the Research Council of Norway to study nasal delivery of oxytocin for the treatment of autism spectrum disorders.
According to OptiNose US, the Phase 3 TARGET study found that 42% of patients with moderate to severe migraines experienced headache relief within 30 minutes after using the OptiNose low-dose sumatriptan powder, and 68% of patients reported relief after two hours. The double-blind, placebo-controlled study had patients use either a 16 mg dose of OptiNose sumatriptan or placebo delivered by the OptiNose device.
Approximately 90% of patients reported that they found the “bi-directional” nasal device easy to use, and about 75% found the device “very or somewhat comfortable to use.” No adverse events were reported.
CEO Peter Miller said, “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. The successful conclusion of our pivotal phase 3 study represents a significant step forward in realizing our goals for improving patient care with our new technology.”
The company also announce an award of 12.3 million Norwegian kroner ($2.1 million) to its Norwegian affiliate from the Research Council of Norway’s program for User-Driven, Research-Based Innovation Research. The money will be used for research on the treatment of autism spectrum disorder using oxytocin delivered by the company’s nasal delivery platform.
OptiNose Chief Scientific Officer Per Djupesland commented, “The opportunity to investigate nose-to-brain drug transport with the OptiNose technology in an effort to develop a new treatment for autism spectrum disorders is very exciting. Autism spectrum disorders are growing in prevalence and there are no drugs approved to treat the core symptoms which burden children, adults and families with these conditions. We hope to see significant benefits from delivering treatment with our innovative nasal technology.”
Read the OptiNose press release on the sumatriptan study.
Read the OptiNose press release on the Norwegian grant.
