I went to high school and college with kids who were diagnosed ADHD and took Ritalin. I never really understood why. I mean isn’t concentration something you learn in grammar school? Would any child choose to focus on their school work unless they were taught how to do so?

You don’t automatically know how to study or prepare for an exam or write a term paper without learning how to do it. I guess when you call a kid spaz and they have some energy, you should just medicate. I really am not looking forward to seeing what happens to my son in a few years when he starts to act up and the psychologist recommends putting him on medication.

There is more technical information at MedScape, but it is not relevant to my comments.

January 9, 2008 — Guanfacine extended release (Shire Inc.) at doses of 2, 3, and 4 mg/day was effective vs placebo and was generally well tolerated in a multicenter, 8-week, fixed-dose escalation study in children aged 6 to 17 years old with attention-deficit/hyperactivity disorder (ADHD).

The study, part of a new drug application, is published in the January issue of Pediatrics.

“I think it is very important for clinicians and families to have alternative treatments…to treat a condition in which many patients cannot tolerate or do not respond to treatment,” lead author, Joseph Biederman, MD, from Massachusetts General Hospital in Boston, told Medscape Psychiatry, adding that guanfacine extended release offers a unique option for patients who do not do well taking other treatments.

Any Stimulant Is Ineffective for 1 in 4 Patients

ADHD is a very prevalent, very morbid disorder, said Dr. Biederman. Although stimulants are the mainstay of treatment, any 1 stimulant is ineffective in 25% to 30% of cases, the group writes.

Guanfacine extended release, a nonstimulant, is an alpha-2 adrenergic agonist like clonidine (Catapres; Boehringer-Ingelheim) but is more selective. Both of these drugs came to market as antihypertensive agents, said Dr. Biederman, adding that they have been used off label in psychiatry for many years for managing withdrawal reactions, treating severe hyperactivity in ADHD, and, more recently, treating insomnia that frequently develops as a consequence of stimulant treatment.

The study aimed to assess the efficacy and safety of guanfacine extended release for the treatment of children and adolescents with ADHD.

The trail was conducted in 48 centers in the United States. Patients aged 6 to 17 years old who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD were eligible to participate.

COMMENTS

Did you read what Guanfacine came on to the market for? Did you read what it was prescribed off label for? These really disturb me that all of a sudden, hey, lets give it to kids who are too stimulated already! I do not know that much about medicine or science, but I would assume that there is a large gap between hypertension and ADHD.

Maybe I am wrong.

When a junkie goes through withdrawal, uh, I guess it is just like a hyperactive child – this sort of makes sense to me with frazzled nerves and brain functions. Also insomnia? I know that for people who do not suffer from ADHD, taking medications that are prescribed for ADHD makes them speedy, but puts them to sleep?

I need to learn more to properly comment on these items, but this is what I thought when I read it.

Stay adherent!

The Food and Drug Administration approved Alliant’s Methylin Chewable Tablets and Methylin Oral Solution and the pediatric specialty pharmaceutical company said the goal is to increase compliance.

Dr. Lyndon Waugh of Emory University said children often have difficulty swallowing pills so the new offerings could help ensure they take their medication. It’s estimated up to 26 percent of the general population has difficulty swallowing tablets and capsules and the percentage is considered higher for children.

ADHD is a brain disorder that causes children to exhibit inappropriate impulsivity or inattention. It is estimated that 7 percent of school-age children and 4 percent of adults suffer from ADHD, one of the most commonly reported behavioral problems.

My Comment

When I was young (34 now), I had the Flintstone chewable vitamins, as well as the St. Joseph’s aspirin, so does this really come as a shock that kids have a difficult time with tablets and pills? Luckily I never suffered from ADHD or any deficit disorders, but hasn’t that been the “easy” diagnosis for doctors for many years now? But 7% doesn’t seem that high. Maybe I’m confused with ADD?

I know the parameters for diagnosing autism in children have gotten less stringent, raising the diagnosed numbers. But shouldn’t ADHD be higher as well?

All I know if that anything pharma does to increase adherence is OK in my book.

05/09/2007 – Shire and Noven Pharmaceuticals have announced the voluntary withdrawal of a limited amount of Attention Deficit Hyperactivity Disorder (ADHD) transdermal patches following reports of a mechanical problem when applying the patch.

Up to five per cent of patients reported having trouble removing the release liner from the sticky part of Daytrana (methylphenidate transdermal system) patches, which are used for the treatment of ADHD.

While the mechanics did not affect the release of the drug, Shire decided to take the “proactive step” to withdraw the product. The UK company, which has the global license for Daytrana, said in a statement the patches could continue to be used as long as they were not damaged.

Meanwhile, Noven and Shire, in the first quarter of this year, implemented enhancements to the Daytrana release liner by increasing the release coating on the liner to provide an easier removal.

The improved patches would replace those being withdrawn, which are Daytrana packages with an expiration date of March 31, 2009 or earlier, and Daytrana packages with lot numbers 2563511, 2563611, 2570411.

The withdrawal was not believed to have any affect on either Shire or Noven or on the patches’ manufacturing, Shire spokeswoman Jessica Mann told in-PharmaTechnologist.com.

The withdrawal should cost less than $10m (€7.35m), according to a report by Reuters.

Daytrana, developed and manufactured by Noven, was approved in the US by the FDA last year, and is the first and only transdermal medication approved to treat the symptoms of ADHD. It is approved for children aged six to twelve years with the disorder.

Since its approval, an estimated 700,000 patches have been sold, with last year’s sales to Shire totalling $8.6m, with $5.9m recognized in related license revenues.

At the end of July, Shire’s net sales of Daytrana exceeded $50m in the 12-months preceding June 30, 2007, triggering a $25m milestone payment to Noven.

The product is based on Noven’s proprietary DOT Matrix transdermal technology, which the company claims has significant advantages over standard patch products.

The system uses a patented multiple adhesive mix of silicone, acrylic and the required drug so that the drug is mixed in with the adhesive that holds the patch on the skin. Each patch is a thin, three-layer laminate made up of the patch backing, the drug/adhesive mix and the release liner (the part that gets peeled off and thrown away once the patch is applied).

The patches themselves are compatible with a wide range of medications, and as they deliver the drug more effectively than other competing products they tend to be smaller than other transdermal systems. In addition to this, the patches use one adhesive to hold the drug, and another to make the patch stick to the skin, resulting in superior adhesion to the skin.

The Noven transdermal system is already in use in other products beyond Shire’s ADHD patch, including DentiPatch (a transmucosal patch for dental pain), Vivelle-Dot (the world’s smallest transdermal estrogen patch), and a number of other hormone therapy patches.

In June, Shire acquired development rights to a new transdermal patch product for ADHD, using amphetamine, after Shire and Noven decided to proceed with clinical development of the patch.

According to Noven, amphetamine products represent about half the US market for stimulant ADHD therapies, and a patch product could bring significant advantages to patients and enhance compliance.

Here are some quick snippets of news from other sources that I have seen this week so far. Sorry for the retread.

At Psychiatry MMC, there is an abstract about short-acting versus long-acting medications for the treatment of ADHD:

“Medication adherence is also a well-known problem in a chronic disorder like ADHD, with only about 20 percent of patients remaining on the same medication 15 months after first being prescribed that medication. The need for multiple daily dosing of immediate-release medications only further increases the risk of nonadherence in children, adolescents, and adults.

As there is a significant likelihood that one of the parents of a child with ADHD will also have ADHD (often undiagnosed), or another psychiatric disorder, there is potentially a significant risk that the parent will forget to give the additional immediate-release doses of medication to the child every 4 to 6 hours.”

Over at MedTrack Alert, they discuss how juices can interfere with medication absorption:

“Researchers say grapefruit juice has been known to dangerously increase the amount of medication absorbed into the body–particularly drugs for high cholesterol and high blood pressure. But a new study by the same researchers has found that apple, orange, and grapefruit juice may also decrease the absorption of some meds, including drugs commonly used to treat diabetes, cancer, allergies, and some antibiotics.”

Dr. Showalter at Alignmap discussed the new medication adherence tool: Zuri. FD it is kind of a competitor to Intelecare, however you do not have to spend $200 on a new device and adapt to new technology – Intelecare works with your existing cellphone, land line and computer. Also, you don’t have to pay $40 – $50 a month for online services.

The Healthcare Blog now has it’s own channel on ICYou. Hat tip to @mindofandre on Twitter.

SHPS to present at Harvard Colloquium about Six Sigma Principles Drive Healthcare Behavior Change — Using Medication Compliance to Improve Healthcare Outcomes.

Over at Health Management Rx, Jen gets exited about the NextHealth Model launching in beta soon.

That is it for now. You can follow me on Twitter and contribute to the conversation.