Zecuity (Transdermal Sumatriptan) Gets FDA Nod for Acute Treatment of Migraine
First agency-approved migraine patch (Jan. 17)
The FDA has approved Zecuity (sumatriptan iontophoretic transdermal system, NuPathe, Inc.) for the acute treatment of migraine with or without aura in adults. The product is a single-use, battery-powered patch that actively delivers sumatriptan, a widely prescribed migraine medication, through the skin. Acute treatment provides relief of both migraine headache pain and migraine-related nausea.
The Zecuity transdermal patch was approved based on the results of phase III trials in which a total of 800 patients used more than 10,000 patches. In these studies, the Zecuity patch was proven to be safe and effective at treating migraine and at relieving its cardinal symptoms — headache pain, migraine-related nausea, and sensitivity to light and sound — 2 hours after patch activation.
In a phase III trial, twice as many patients treated with the Zecuity patch achieved relief from headache pain at 2 hours after activation compared with placebo (18% vs. 9%, respectively). In addition, 53% of patients treated with Zecuity achieved relief from headache pain, and 84% were nausea-free at 2 hours after activation (corresponding placebo rates: 29% and 63%). The incidence of triptan-associated adverse events — “atypical sensations” and “pain and other pressure sensations” — was 2% each in Zecuity-treated patients. The most common side effects associated with the Zecuity patch were application-site pain, tingling, itching, warmth, and discomfort.
Zecuity is a single-use, battery-powered patch applied to the upper arm or thigh during a migraine. It should not be applied to other areas of the body. Following application and with the press of a button, Zecuity initiates transdermal delivery of sumatriptan, bypassing the gastrointestinal tract. Throughout the 4-hour dosing period, the microprocessor within the Zecuity patch continuously monitors skin resistance and adjusts drug delivery accordingly to ensure delivery of 6.5 mg of sumatriptan.