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Drug/Device Therapy Trial Shows Fast Migraine Relief

Migraine pain

(R. Nial Bradshaw, Flickr)

30 October 2014. A late-stage clinical trial shows a medical device designed to deliver migraine drugs deep into nasal cavities achieved headache relief in as little as 30 minutes among patients, and sustained that relief for as long as 48 hours compared to a placebo. The biopharmaceutical company Avanir Pharmaceuticals Inc. in Aliso Viejo, California licensed the drug delivery technology last year from OptiNose, which led the trial. The findings appear today online in the journal Headache.

Migraine is a neurological syndrome causing severe headaches along with nausea, vomiting, and extreme sensitivity to light and sound. In some cases, migraines are preceded by warning episodes called aura including flashes of light, blind spots, or tingling in arms and legs. Migraine Foundation says the syndrome is one of the top 20 disabling disorders and estimates some 36 million people suffer migraines in the U.S., including 14 million who experience migraines nearly every day or more often.

The Avanir/OptiNose solution delivers sumatriptan, a widely used migraine drug, in powder form. Sumatriptan, approved by FDA in 1992, stimulates serotonin receptors in the brain. Serotonin is a neurotransmitter chemical generated in the brain, regulating signals between neurons that helps maintain mood balance. Decreased levels of serotonin are associated with depression.

The Avanir/OptiNose device, code-named AVP-825, aims to bypass a problem with sumatriptan in pill form, namely its absorption in the stomach which delays and impedes reaching the areas of the brain where the drug is needed. The device carries a measured dose of the medication in dry powder form, with a piece that fits in the patient’s nostril and a separate piece that goes in the mouth. The patient exhales into the device, which sends the dose of sumatriptan into the nose and into the nasal passages, deeper than can be delivered with a nasal spray, according to OptiNose, for transfer into the blood stream near the brain.

The clinical trial tested AVP-825 to deliver a lower dose (22 milligrams) of sumatriptan against a placebo, in this case a lactose powder also delivered with a similar device, among 230 migraine patients in the U.S. The patients were randomly divided between those receiving sumatriptan or the placebo. The primary objective of the trial was to measure the extent of relief from headache pain within 2 hours, in cases of a single moderate or severe migraine attack.

The results show a more patients using AVP-825 (42%) achieved headache relief as soon as 30 minutes after the treatment, compared to those receiving the placebo (27%). After 2 hours, about two-thirds (68%) of the patients using AVP-825 were headache-free, compared to 45 percent with the placebo. Total migraine symptom relief — headache, nausea, sound and light sensitivity — were experienced by 19 percent of the patients with AVP-825, compared to 9 percent of the placebo patients.

In addition, the pain relief was sustained at 24 and 48 hours following the treatments in greater proportions among AVP-825 patients than with placebo patients. No serious adverse reactions were reported in the trial. One patient taking AVP-825 reported mild skin tingling, called paresthesia.

Avanir says it submitted a new drug application for AVP-825 with FDA, which set 26 November 2014 as its target date for completing the review.

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