FDA Approves NuPathe’s Zecuity as New Migraine Treatment

Andrew Klips  |

Shares of NuPathe Inc. (PATH) are trading ahead on Friday after reporting late Thursday that the U.S. Food and Drug Administration has approved Zecuity, the company’s new treatment for migraines with or without aura in adults. Zecuity (sumatriptan iontophoretic transdermal system) 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) and will be available as an alternative to today’s oral, nasal and injectable medicines.

The patch is applied to the upper arm or thigh during a migraine and activated with the push of a button to start a four-hour dosing period.

The Conshohocken, Pennsylvania-based maker of neurological and psychiatric medicines now plans to focus it energies on manufacturing the patches and securing commercial partners for a fourth-quarter launch of Zecuity.

This wasn’t the first go-around with the FDA for Zecuity. In August 2011, the regulatory agency declined approval of the treatment because of safety concerns stemming from skin reactions. After a re-design, NuPathe has now garnered the FDA blessings. The label includes a warning about possible allergic contact dermatitis.

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"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,” said Armando Anido, CEO of NuPathe, in a statement.

Migraines are a neurological disorder affecting 36 million Americans, or about 12 percent of the population, according to the American Migraine Foundation. Untreated, migraines typically last between 4 and 72 hours. Some treatments that are commonly used today include Zogenix, Inc.’s (ZGNX) Sumavel, an injectable that sells for $95 per dose. No pricing for Zecuity has yet been released.

In phase 3 trials, Zecuity was studied in trials comprised of 800 patients using more than 10,000 Zecuity patches. The trials showed the product to be safe and effective; relieving the key symptoms in 18 percent of the subjects two hours after patch activation, compared to 9 percent in the placebo group. Further, 53 percent of patients treated with Zecuity achieved relief from headache pain and 84 percent were nausea-free at two hours, compared to 29 percent and 63 percent, respectively, for the placebo arm.

Shares of PATH galloped ahead to $3.93 shortly after the opening bell Friday, but have slipped to $3.56 one hour into the trading session for a gain of 7.5 percent from Thursday’s closing price. With today’s move, shares are ahead more than 40 percent since November lows.

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