Skin Patch For Migraines Receives FDA ApprovalMain Category: Headache / Migraine
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 20 Jan 2013
The FDA has approved Zecuity (sumatriptan iontophoretic transdermal system) for the treatment of acute migraine in adults with or without aura.
Zecuity is a battery-powered skin patch that delivers sumatriptan through the patient's skin - it is a single-use medication.
Sumatriptan is the most extensively prescribed migraine drug. According to NuPathe Inc., the makers and marketers of Zecuity, the patch is effective in treating migraine headache pain as well as migraine-related nausea.
Armando Anido, CEO of NuPathe, said, "The approval of Zecuity represents a major milestone for NuPathe and migraine sufferers. 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."
Lawrence C. Newman, MD, FAHS, FAAN, Director of the Headache Institute at St. Luke's-Roosevelt Hospital, New York, explained that apart from painful headaches, people with migraine often have other symptoms, including nausea (migraine-related nausea, or MRN). For these other symptoms, doctors need to assess each individual patient and offer tailored treatments.
Zecuity is the first skin patch approved for the treatment of migraine.
Study researcher, Stephen D. Silberstein, MD, FACP, FAHS, FAAN, Professor of Neurology and Director of the Jefferson Headache Center in Philadelphia, said that migraine-related nausea can be as incapacitating as a migraine headache. Treatments for such patients should bypass the gastrointestinal tract, he added.
An analysis of the National Headache Foundation's landmark American Migraine Prevalence and Prevention (AMPP) Study in 2011 found that migraine with nausea is significantly debilitating.
Zecuity migraine patch is both safe and effective in human trialsThe FDA examined the findings from Phase III trials involving over 800 patients and more than 10,000 Zecuity skin patches. The studies showed that Zecuity is both safe and effective in the treatment of migraine as well as relieving its cardinal symptoms, which include severe headache, migraine-related nausea, photophobia and sensitivity to sound, within two hours of placing the patch on the skin.
A Phase III pivotal study showed that:
About Zecuity (sumatriptan iontophoretic transdermal system)Zecuity (sumatriptan iontophoretic transdermal system) is indicated for the acute treatment of migraine with or without aura for patients aged 18+ years. The single-use, battery-powered patch is placed on the thigh or upper arm during a migraine.
After placing the patch on the skin, the patient presses a button and Zecuity starts delivering the active ingredient transdermally (through the skin), thus bypassing the GI (gastrointestinal) tract.
During the whole four-hour dosing period, a microprocessor inside Zecuity continuously monitors skin resistance and adjusts the delivery of the drug accordingly to make sure 6.5 mg of sumatriptan is delivered.
Important safety information for Zecuity migraine patchYou should not take Zecuity if you have problems with blood circulation, uncontrolled hypertension, migraines that cause temporary paralysis to one side of the body, basilar migraine, Wolff-Parkinson-White syndrome, a history of heart disease or stroke, peripheral vascular disease, transient ischemic attack, or some type of heart rhythm disturbance. On very rare occasions, some patients without heart disease have experienced serious heart-related problems after taking triptans.
If you have taken other migraine drugs, such as ergotamine medication or other triptans within the last 24 hours you should not use Zecuity. Patients who have taken MAO-A (monoamine oxidase-A) inhibitors within the last two weeks should not take Zecuity.
Do not use Zecuity if you are undergoing MRI (magnetic resonance imaging).
If you have an allergy to sumatriptan or components of Zecuity, or if you had allergic contact dermatitis after using Zecuity, you should not use Zecuity. If you do develop allergic contact dermatitis following treatment with Zecuity, tell your doctor.
In an online communiqué, NuPathe wrote "ZECUITY, like other triptans, may be associated with a potentially life-threatening condition called serotonin syndrome, mainly when used together with certain types of antidepressants including serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). Patients should tell their healthcare provider before using ZECUITY if they have heart disease or a family history of heart disease, stroke, high cholesterol or diabetes; have gone through menopause; are a smoker; have had epilepsy or seizures or if they are pregnant, nursing or thinking about becoming pregnant."
Click here for full prescribing information for Zecuity.
Doctors and patients should report any side effects related to taking prescription medications to the FDA, by either visiting www.FDA.gov/medwatch, or telephoning 1-800-FDA-1088.
Written by Christian Nordqvist
Copyright: MediLexicon International Ltd
Original article posted on Medical News Today.
Articles not to be reproduced without permission of Medical News Today