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Breath-Powered Intranasal Sumatriptan Has Rapid Absorption, Provides Fast Migraine Relief

VBCN - July 2014 Volume 1, No 2 - Migraine
Wayne Kuznar

Philadelphia, PA—A breath-powered intranasal powder form of sumatriptan produces fast and sustained relief of migraine, according to the results of a phase 3, placebo-controlled trial presented at the 2014 American Academy of Neurology meeting.

Approximately 66% of patients using the powder form of sumatriptan had headache relief within 2 hours, and more than 33% were pain-free; these effects were maintained for 48 hours.

This new delivery system uses a closed-palate breath-powered device to deliver sumatriptan powder to deep nasal passages, where it is absorbed faster compared with conventional nasal sprays, said Roger K. Cady, MD, Founder, Headache Care Center, Springfield, MO, and lead investigator of the study.

Patients with migraine frequently cite the slow onset of action of oral triptans as a reason for dissatisfaction, Dr Cady said.

“This is really a very unique way of delivering drugs using the nasal mucosa,” said Dr Cady. “The standard liquid-based nasal sprays can be very useful, but the problem is that often the spray doesn’t get beyond the nasal valve and tends to run out the front. And if it gets on the floor of the nasal cavity, it’s often swallowed. So, very often the results are inconsistent.”

The breath-powered device counters these potential problems. One part of the device is placed into the nostril and the other part in the mouth. “Instead of trying to coordinate sniffing and spraying, the patient blows out, and then the device delivers a powder form of sumatriptan, which adheres to the nasal mucosa,” Dr Cady said. The region deep into the nasal cavity has a large surface to facilitate rapid absorption. In a pharmacokinetic study, the intranasal powder form of sumatriptan absorbed faster than the conventional nasal spray.

The intranasal powder form was tested in a phase 3, multicenter, double-blind, placebo-controlled, single-­dose, parallel-group study of 230 patients who had 1 to 8 migraines monthly in the previous 12 months. For the treatment of a single migraine of moderate or severe intensity, patients received 1 half-dose of powder sumatriptan (11 mg per capsule, for a total of 22 mg of sumatriptan) delivered into each nostril or placebo.

At 120 minutes after dosing, 68% of patients assigned to powder sumatriptan reported headache relief compared with 45% of patients receiving placebo (P <.01). The difference in headache relief between the 2 groups achieved statistical significance (P <.05) at 30 minutes, when 42% of patients receiving active treatment and 27% receiving placebo reported relief.

Meaningful relief (70% vs 45%, respectively; P = .004) and complete relief (34% vs 17%, respectively; P = .008) of headache also occurred significantly more often at 120 minutes with powder sumatriptan than with placebo. Sustained headache relief and sustained freedom from pain (at 24 hours and 48 hours) without rescue medication were significantly more likely with active treatment, and rescue medication was required significantly less often in patients assigned to powder sumatriptan compared with placebo (37% vs 52%, respectively; P <.05).

“Given the small drug exposure, there are very few side effects that we would associate with triptans,” said Dr Cady.

The incidence of migraine-associated symptoms, such as nausea, vomiting, photophobia, and phonophobia, was reduced with powder sumatriptan, but the differences failed to achieve significance.

The most common adverse events associated with powder sumatriptan were product taste, nasal discomfort, and rhinitis; these were transient and mostly of mild-to-moderate severity. There were no serious adverse events in the active treatment group.

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