redOrbit Staff & Wire Reports – Your Universe Online
The Food and Drug Administration (FDA) has approved Zecuity, a skin patch used to treat migraine headaches, making it the first product of its kind to be cleared for sale in the US.
Zecuity is manufactured by Pennsylvania-based NuPathe Inc, and according to Bloomberg reporter Ryan Flinn, it uses a “mild electrical current” to administer sumatriptan, “the most-prescribed migraine headache medication” in America, to patients suffering from debilitating migraines.
NuPathe CEO Armando Anido told Flinn that he expects the product to go on sale during the fourth quarter of 2013, and that his company was currently “in conversations with a number of people” regarding possible distribution partnerships. Zecuity had previously been denied by the FDA due to safety concerns, but Anido said that the company had since redesigned it to prevent possible skin reactions.
MedPage Today Staff Writer Cole Petrochko explains that the transdermal patch can be used to treat both pain and nausea associated with the debilitating headaches, and is effective for migraines both with and without aura.
Zecuity, which is a single-use, battery-powered patch, is applied to either the upper arm or the thigh when symptoms are present. Once activated, it delivers a 6.5mg dose of sumatriptan over a four-hour period, Petrochko said. He added that the treatment system received the go-ahead from the FDA “based on the results of a phase III, placebo-controlled trial of 800 patients that showed the sumatriptan delivery method was safe and effective.”
In a statement, the company said that 18-percent of those who used the newly approved product were free of pain symptoms within two hours, versus just 9-percent among those who took placebo.
Furthermore, they said that 53-percent of Zecuity patients reported some degree of pain relief, and 84-percent were nausea free two hours after using the treatment (versus 29-percent and 63-percent for the placebo group).
“The approval of Zecuity represents a major milestone for NuPathe and migraine sufferers,” Anido said. “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.”
“Anido declined to say how much the patch would cost, though he indicated it would be comparable to the $95 that a similar medication costs as an injection,” Flinn added.