NuPathe announced that the FDA has approved Zecuity (sumatriptan iontophoretic transdermal system) for the acute treatment of migraine with or without aura in adults. Zecuity is a single-use, battery-powered patch that actively delivers sumatriptan, a selective 5-HT1B/1D receptor agonist, through the skin.
Zecuity was approved based upon an extensive development program with Phase 3 trials that included 800 patients using >10,000 Zecuity patches. In these trials, Zecuity was proven safe and effective at treating migraine and relieving its cardinal symptoms (headache pain, migraine-related nausea and sensitivity to light and sound) two hours after patch activation. In the Phase 3 pivotal study, twice as many patients treated with Zecuity achieved freedom from headache pain at two hours compared with placebo (18% and 9%, respectively). Additionally, 53% of patients treated with Zecuity achieved relief from headache pain and 84% were nausea free at two hours (29% and 63%, respectively, with placebo).
Zecuity is applied to the upper arm or thigh during a migraine. Throughout the four-hour dosing period, the microprocessor within Zecuity continuously monitors skin resistance and adjusts drug delivery accordingly to ensure delivery of 6.5mg of sumatriptan.
Zecuity is expected to be available in the fourth quarter of 2013.
For more information call (484) 567-0130 or visit www.zecuity.com