Novel Nasal Drug Delivery System Shows Promise in Migraine

Pauline Anderson

November 15, 2012

A novel nasal drug delivery system provides migraine relief to some patients in as little as 15 minutes, according to topline results from a phase 3 study investigating the breath-powered bi-directional nasal spray.

The device, which delivers a powder form of sumatriptan (Imitrex, GlaxoSmithKline) and is manufactured by OptiNose, reaches target areas of the nasal cavity more effectively than do traditional nasal sprays while using less medicine, according to a company press release.

Information on the company's Web site suggests that much of the medicine in traditional nasal sprays gets lost in the throat and stomach, where its effects are delayed or even undermined by the digestive process. In contrast, the OptiNose breath-powered nasal delivery system administers drugs deep in the nasal cavity.

In the placebo-controlled, multicenter study, 212 patients with migraine were randomly assigned to a placebo or the sumatriptan device and advised to use it for moderate to severe migraine pain. Investigators used a 4-point scale to assess headache relief, defined as a reduction from moderate (grade 2) or severe (grade 3) pain to mild (grade 1) or complete (grade 0) relief.

The study showed that almost 42% of patients taking 16 mg sumatriptan administered through the treatment device reported migraine relief in 30 minutes (P < .05 vs placebo). About 68% of patients experienced pain relief after 2 hours (P < .01 vs placebo).

The data showed that pain relief for some patients began as early as 15 minutes after treatment, and a statistically significant greater number of patients receiving OptiNose-delivered sumatriptan experienced headache relief compared with placebo at all times from 30 minutes through 2 hours.

"This is the first migraine treatment to deliver medicine using a special new type of nasal device and also the first to use a powder form of sumatriptan," said Roger K. Cady, MD, director of the Headache Care Center, Springfield, Missouri, and associate executive chairman of the National Headache Foundation, in the press release. "The treatment tested in this trial uses OptiNose technology to deliver a surprisingly low dose of a proven medicine in a unique new way."

He added that rapid relief can be very important for migraine sufferers because symptoms often come on fast and can be debilitating.

The study uncovered few adverse events.

The device also had a significant effect on quality of life, with users reporting a statistically significantly lower clinical disability rating than those receiving placebo.

Almost 90% of patients in the study found the device to be very or somewhat easy to use, and about 3 of 4 found it very or somewhat comfortable to use.

To operate the powder delivery system, a patient inserts a disposable section into the device and depresses a button on the side, which activates steel pins on the side that pierce the capsule. The patient slides the nosepiece into the nostril and the mouthpiece between the lips, takes a deep breath, closes the lips around the mouthpiece, and exhales, delivering drug into the nasal cavity.

Many of the estimated 30 million Americans with migraine are dissatisfied with current treatments.

OptiNose has launched a study to directly compare the efficacy and tolerability of OptiNose sumatriptan with those of sumatriptan tablets. The study will assess the speed of headache relief and various other measures of efficacy and treatment related adverse effects.

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