Main Category: Headache / Migraine
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 20 Jan 2013 - 1:00 PST
Current ratings for:
Skin Patch For Migraines Receives FDA Approval
| Patient / Public: |  |
|
| Healthcare Prof: |  | 4.25 (4 votes) |
| Article opinions: | 3 posts |
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."
Zecuity is the first skin patch approved for the treatment of migraine
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.
According to the American Academy of Neurology, migraine patients who have nausea symptoms should not take medications via the mouth (oral route), because of the risk of vomiting.
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 trials
The 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:
- 18% of patients using Zecuity achieved freedom from headache pain within two hours, compared to 9% on placebo
- 53% of patients on Zecuity eventually achieved relief from headache pain, compared to 29% on placebo
- 84% of patients on Zecuity achieved total relief from nausea symptoms within two hours, compared to 63% of those on placebo
- 2% of patients on Zecuity experienced triptan-associated adverse events, including atypical sensations, pain and other pressure sensations
- Over 5% of patients experienced the following side-effects after taking Zecuity - site pain, tingling, discomfort, warmth, itching and discomfort.
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 patch
You 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: Medical News Today
Not to be reproduced without permission of Medical News Today
MLA
n.p. "Skin Patch For Migraines Receives FDA Approval." Medical News Today. MediLexicon, Intl., 20 Jan. 2013. Web.
25 Jan. 2013. <http://www.medicalnewstoday.com/articles/255153.php>
APA
http://www.medicalnewstoday.com/articles/255153.php.
Please note: If no author information is provided, the source is cited instead.
Visitor Opinions (latest shown first)
how fast is the skin patch in working vs oral administration - migraine patch
posted by Kevin Cease on 23 Jan 2013 at 4:03 pmhow does this compare to the oral dose as far as how fast relief is achieved?
Why not ODTs?
posted by Lori on 20 Jan 2013 at 6:42 pmRather than develop a new and expensive delivery system, i.e. a battery-operated, single-use transdermal patch, why not just manufacture more migraine medications as orally disintegrating tablets that are absorbed buccally? This article makes it seem as though the reason this patch was developed was to ensure absorption of the med before a migraine-induced vomiting episode. Orally disintegrating tablets already solve this problem.
Also, I have to agree with Brandon. For me, vomiting almost always provides some relief during a migraine!
Vomiting actually seems to help my migraines.
posted by Brandon on 20 Jan 2013 at 2:47 amI always look forward to vomiting when I have a migraine. Not sure why, but after I vomit, I find it easier to to get to sleep and wake up without a migraine. Without vomiting, I just toss toss and turn in agony and can't get to sleep. Even if I do get to sleep, it seems like I'm much more likely to wake up with a headache if I haven't vomited.
Add Your Opinion On This Article
'Skin Patch For Migraines Receives FDA Approval'Please note that we publish your name, but we do not publish your email address. It is only used to let you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.
If you write about specific medications or operations, please do not name health care professionals by name.
All opinions are moderated before being included (to stop spam)
Contact Our News Editors
For any corrections of factual information, or to contact the editors please use our feedback form.
Please send any medical news or health news press releases to:
Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.
No comments:
Post a Comment