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NuPathe achieves top-line results for migraine patch

Published: 20:50 03 Oct 2011 BST

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NuPathe (NASDAQ:PATH) announced Monday it achieved top-line results at its NP101-009 study for its NP101 drug, marketed as Zelrix, intended for the treatment of migraines.

The 12-month, repeat use, safety trial assessed the long-term safety of the Zelrix patch. The study enrolled 479 patients, each of whom used the patch at least once. Only four patients experienced triptan sensations, which include chest tightness, flushing, and feelings of pressure and numbness.

Chief Scientific Officer, Dr. Mark Pierce said: "We now have treated more than 800 patients who applied greater than 10,000 patches in our Phase III clinical program. Our clinical data have consistently shown a very low rate -- 1.4 percent in fact -- of triptan sensations across patients who have used our patch to treat their migraine."

The Zelrix patch uses sumatriptan, a drug that is commonly used in the treatment of migraines. The patch's non-oral property provides fast-acting and sustained relief of common migraine symptoms, including headache pain, migraine-related nausea, and sensitivity to light and sound.

NuPathe said its patch technology is more efficient than traditional orally-administered medication, as it by-passes the gastrointestinal tract, which slows during a migraine attack.

The results of the study will go toward fulfilling the recommendations made in the Complete Response Letter provided to NuPathe by the FDA in late August 2011, following the company's original new drug application (NDA).

The letter addressed certain chemistry, manufacturing and safety questions, though NuPathe did not specify.

NuPathe CEO Jane Hollingsworth said: "Based on the extensive clinical data from our entire Phase III clinical program, we believe that our patch will provide a valuable new treatment option that is particularly well-suited for the millions of migraine patients who suffer from debilitating migraine-related nausea along with their headache pain. We plan to present detailed results from the NP101-009 trial at an upcoming scientific meeting."

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