NuPathe Inc. out of Conshohocken, Pennsylvania won FDA clearance for its novel ZECUITY sumatriptan iontophoretic transdermal system to help address acute migraines. Sumatriptan is a popular drug for fighting migraines, but taking it orally is not easy if you’re also nauseous due to the headache.
The ZECUITY is a single use battery powered patch that delivers sumatriptan through the skin at the press of a button. It uses an electric current to pull ionized drug particles through the skin while monitoring the skin’s resistance to the transfer of sumatriptan during the the four-hour dosing.
From the announcement:
Zecuity was approved based upon an extensive development program with phase 3 trials that included 800 patients using more than 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). The incidence of triptan-associated adverse events known as “atypical sensations” and “pain and other pressure sensations” was 2% each in Zecuity-treated patients. The most common (greater than 5%) side effects of Zecuity were application site pain, tingling, itching, warmth and discomfort.
Product page: ZECUITY…
Press release: NuPathe’s Zecuity Approved by the FDA for the Acute Treatment of Migraine
Flashbacks: Zelrix Sumatriptan Anti-Migraine Patch Going to FDA for Review; Zelrix, A Migraine Patch, Is Moving Forward
