Success for New ADHD Patch
There are patches for quitting smoking, and patches for birth control — so why not a patch for ADHD? Early clinical trials suggest that a methylphenidate transdermal system (MTS), or patch, demonstrated statistically significant reductions in the symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) and was generally well tolerated in patients aged 6 to 12.
About the ADHD Patch
With typical drug company self-promotional flare, a press release this morning described the initial results of clinical trials for the methylphenidate transdermal system:
“Children with ADHD must cope with symptoms throughout the day and in a variety of environments, such as in the classroom, during after-school activities, or while at home,” explained Sharon Wigal, Ph.D., associate clinical professor of Pediatrics at the University of California, Irvine Child Development Center. “While oral methylphenidate has long been a first-line treatment for patients with ADHD symptoms, if approved, this transdermal patch formulation would provide health care professionals and parents the first and only non-oral medication for children with the disorder.”
The MTS patch was developed by Noven Pharmaceuticals, Inc. and combines the active ingredient of methylphenidate with Noven’s patented DOT Matrix transdermal technology. This transdermal delivery system was designed to provide continuous medication release throughout the day. The transdermal system releases medication that passes through the skin and directly into the blood stream. The patch is water-resistant.
The press release goes on:
In the phase III naturalistic trial with 270 participants, investigators found that MTS worn for nine hours reduced the children’s overall symptoms of ADHD, compared to a placebo (P < 0.0001), as measured by scores on the ADHD Rating Scale (ADHD-RS). By the study's end, mean ADHD-RS scores declined –24.2 points (56%) from baseline for children treated with MTS versus a decline of –9.9 (24%) for those treated with placebo (P < 0.0001). ADHD-RS assesses 18 individual symptoms of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, a publication of the American Psychiatric Association.
In both studies, MTS was generally well tolerated during both the dose optimization and double-blind phases. Adverse events typically were mild to moderate, resolved with continued therapy and were consistent with known effects of methylphenidate. The most common adverse events reported by patients who received MTS in clinical trials were: nausea, vomiting, nasopharyngitis, weight decreased, anorexia, decreased appetite, affect lability, insomnia, tic, and nasal congestion.
About MTS
MTS is not intended to be administered to patients with: marked anxiety, tension or agitation; allergies to methylphenidate or other ingredients in MTS; skin sensitivities to soaps, lotions, cosmetics or adhesives; eczema, psoriasis, dermatitis or sensitive skin syndrome. MTS has not been studied in children under 6 years of age. Patients will be advised to avoid direct external heat to the patch application site. MTS will need to be stored in a safe place, out of the reach of children.
Methylphenidate should not be administered to patients with: glaucoma; tics, Tourette’s syndrome or a family history of Tourette’s syndrome; current or recent use of Monoamine Oxidase Inhibitors (MAOIs). Chronic abuse of methylphenidate may lead to dependence and careful supervision following withdrawal from abuse is warranted. Methylphenidate should not be given to patients with a history of drug dependence or alcoholism. Methylphenidate should not be used for the prevention or treatment of severe depression or normal fatigue states. Growth should be monitored in patients treated with methylphenidate. Use with caution in patients with psychosis, history of seizures or EEG abnormalities, hypertension, and history of drug dependence or alcoholism. Rare cases of visual disturbances have been reported with methylphenidate use. Hematologic monitoring is advised during prolonged therapy.
About ADHD
ADHD affects approximately 7.8 percent of all school-age children, more than 4 million in the United States. ADHD is considered the most commonly diagnosed psychiatric disorder in children and adolescents. ADHD is a neurological brain disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable age and maturity. If untreated, ADHD can acutely affect a child’s life, leading to problems with family members, friends, sports, after-school activities and academics.
Problems With the Daytrana Patch?
UPDATE, APRIL 2007: Please note we’ve begun a new discussion thread (“Problems With the Daytrana ADHD Patch?”) where visitors are reporting on their experiences — both good and bad — with the new ADHD patch.
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Other articles by Dr Greg Mulhauser, Managing Editor
This article was last reviewed by on Monday, 24th October 2005. Comments are currently closed.
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17th November 2005
How much methylphenidate (MPH) is there in the patch?
How much is delivered each hour? Is tehre any variation in the amount that is delivered each hour? What are thh side effect profiles as compared to other MPH products such as Ritalin-LA,Metadate CD adn Concerta?
17th November 2005
Hi folks,
More information on Shire’s NDA (New Drug Application) for the methylphenidate transdermal system for ADHD is available from their website or their earlier NDA press release.
All the best,
Greg
5th August 2006
[...] Following up on our earlier article on the methylphenidate transdermal system for ADHD, it looks like the FDA is now set to approve an ADHD patch from Noven Pharmaceuticals and Shire Pharmaceuticals Group, which co-developed the patch: In a letter to Noven Pharmaceuticals Inc., the Food and Drug Administration included proposed changes to how the patch is labeled, the Miami-based company said. The FDA also asked that the company clarify some data and conduct surveillance and study of the product once it is on the market. The patch would be sold under the name Daytrana. [...]
2nd November 2006
I want to know if there is a patch for ADHD out there that is NOT a stimulant.
3rd April 2007
What about different area’s used to apply the patch, not just the hip. Is there different delivery times in this? thanks
3rd April 2007
Hi folks,
Please note we’ve started a newer discussion thread for visitors to stay abreast of the latest user experiences with the patch — both problems and solutions!
All the best,
Greg