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news.Optinose, the Norwegian drug delivery specialists, has presented positive Phase I data that could lead to faster, effective and less invasive relief for migraine sufferers.
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The recently completed trial first demonstrated that Sumatriptan powder delivered intranasally using OptiNose’s second generation device has a rapid onset of action and is as effective as subcutaneously administered Sumatriptan in preventing GTN Challenge Induced EEG changes in migraine sufferers.
In the trial, pharmacokinetics data showed that Sumatriptan powder at doses of 10mg or 20mg delivered intranasally by the OptiNose device was rapidly absorbed with a median tmax of 20 minutes, which is 70 minutes earlier than the marketed sumatriptan nasal spray. There were no reports of bad aftertaste. Regarding efficacy, the trial showed that the mean qEEG changes for Optinose Intrasanal Sumatriptan powder are similar to SC. The company now looks forward to presenting further Phase II data later in 2008.
Helena Djupesland, Optinose’s CEO, said: “The breath-actuated OptiNose device represents a major advance by delivering the drug dose primarily to the highly vascularized mucosa beyond the nasal valve and accelerating onset of action.”