CONSHOHOCKEN, PA -- (Marketwire) -- 01/17/13 -- NuPathe Inc. (NASDAQ: PATH) today announced that the U.S. Food and Drug Administration (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, the most widely prescribed migraine medication, through the skin. Zecuity provides relief of both migraine headache pain and migraine-related nausea (MRN).
"The approval of Zecuity represents a major milestone for NuPathe and migraine sufferers," said Armando Anido, CEO of NuPathe. "As the first and only FDA-approved migraine patch, we believe Zecuity will be a game-changing treatment option for millions of migraine patients, especially those with migraine-related nausea. We thank the patients and physicians who participated in our clinical trials as well as our employees for their support throughout the development of Zecuity. We now intensify our focus to securing commercial partners and preparing for the launch of Zecuity expected in the fourth quarter of this year."
"In addition to severe headache pain, migraine patients present with other significant symptoms, which commonly includes migraine-related nausea," said Lawrence C. Newman, MD, FAHS, FAAN, Director of the Headache Institute at St. Luke's-Roosevelt Hospital in New York. "For these patients, physicians need to assess and offer treatments tailored to each individual patient's array of migraine symptoms. In fact, the American Academy of Neurology guidelines recommend a non-oral route of administration for migraineurs who experience nausea or vomiting as significant symptoms."
"Migraine-related nausea can be as debilitating as migraine headache pain itself," said study investigator Stephen D. Silberstein, MD, FACP, FAHS, FAAN, Professor of Neurology and Director of the Jefferson Headache Center in Philadelphia. "Treatments bypassing the GI tract may be the best way to treat these patients."
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.
Most Popular Stories
- Hezbollah Chief's Assassination Claimed by Sunni Group
- Allstate Seeks to Invest in Minority Firms
- Stolen Cobalt-60 Recovered in Mexico
- SpaceX's Satellite Launch Is 'Game-Changer'
- White House Pushes to Extend Unemployment Benefits
- Latin Music Conference Turns 25
- First-time Jobless Claims Drop Below 300,000
- Sarmiento to Handle Greeley Latin Ops
- U.S. Growth Stayed Steady During Shutdown, Fed Says
- Calif. Likes Christie, Says Tea Party's a Drag