Those people who suffer from severe and debilitating migraines will be pleased to hear that new relief is one step nearer thanks to NuPathe's Zelrix Patch. With the positive results achieved during its phase III clinical trial in 2009 the United States Food and Drug Administration (FDA) is currently reviewing the application and a result is expected by the end of August, 2011.
Zelrix is a single-use transdermal patch worn to deliver the migraine medication sumatriptan directly into the blood stream using SmartRelief, NuPathe's transdermal delivery technology. The patch uses a small electrical current to administer the anti-migraine drug through the skin, in a process known as iontophoresis. The patch delivers a controlled amount of sumpatriptan fast and accurately.
One common complaint among acute migraine sufferers is that the nausea and vomiting that accompanies a migraine can be so severe that often they postpone or avoid taking medicine. NuPathe has addressed this problem and believe that the patch will eliminate the need for oral medication that, not only can take up to an hour to offer relief, but also relies on the stomach to absorb it.
“The FDA's acceptance of our NDA brings us one step closer to providing an attractive option to the millions of undeserved migraine patients,” said Jane Hollingsworth, chief executive officer of NuPathe.
“By avoiding oral administration and controlling delivery of sumatriptan within our SmartRelief technology we believe Zelrix overcomes the limitations of current migraine medications."
One of the most common treatments for migraines are triptans which, according to the World Health Organization (WHO), constituted 94 percent of the 13 million prescriptions filled in 2010. Triptans can also have negative side-effects, including tightness and heaviness in the chest, parasthesis and panic attacks.
It is believed that migraines are caused by the change in levels of the chemical in the brain called serotonin. This causes enlarging of blood vessels. Chemicals are released from nerve fibers around these blood vessels releasing chemicals causing inflammation and pain.