Posts Tagged ‘Skin patches’

EU Approval for Exelon

09/20/2007 , 10:44 AM by Alex Sicre

I have writen about patches in the past – both pro and con. With the EU approval of Exelon, caregivers and patients with Alzheimer’s have reason to cheer for better medication adherence. I can only imagine how difficult it must be to care for a parent or spouse with Alzheimer’s – not to mention their medication regime. Hopefully the Exelon patch will have a successful launch and adoption in the EU.

The Exelon patch was approved in the US in July and some expect sales to reach the $1B mark.

Here is a blurb from 9/24 Nursing In Practice website, no author provided:

The European Commission has on today approved the use of a transdermal patch to deliver medicine to patients with mild-to-moderately severe Alzheimer’s disease. The patch is the first type of transdermal treatment for Alzheimer’s disease and is applied once a day to the back, chest or upper arm of patients.

Experts say the patch improves compliance for Alzheimer’s patients and also reduces side-effects.

“All these benefits offer the potential for improved outcomes in patients,” said James Shannon, global head of development at Novartis Pharma.

“Exelon patch represents a therapeutic innovation that is designed specifically to meet the needs of patients, caregivers and physicians involved with this devastating disease.”

Bruno Dubois, Professor of Neurology in Paris, France, agrees that the patch provides vital reassurance that patients have “taken” their medicine, adding: “Just having to apply a patch can help reduce the burden of family life for people with Alzheimer’s disease and their families.”

In a survey of Alzheimer’s caregivers, 70% said they preferred the patch to oral medicines as it helped them follow their treatment schedules and was easier to use.

“People with Alzheimer’s disease and their caregivers welcome every new therapy for the disease,” said Mark Wortmann, executive director of Alzheimer’s Disease International. “I am pleased that the patch offers a new approach to treatment.”

More Problems with Skin Patches

09/05/2007 , 10:59 AM by Alex Sicre

I found this article on the website in-pharmatechnologist.com – a website I have never heard of until today. I think that the use of patches are fantastic for medication adherence, but as you can see, some have their problems. Written by Katrina Megget.

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.

Problems with Skin Patches

08/13/2007 , 10:36 AM by Alex Sicre

I have always been a big fan of medication patches from the begining for medication adherence. I remember first seeing “the patch” for smoking sensation and am glad that they are able to adapt this technology for Alzheimer’s and Parkinson’s. Although I do remember my father smoking and chewing Nicorette while using the patch, and getting incredibly sick.

I had heard about problems with the contraceptive patch, but had never heard of a narcotic patch. I can see how these problems can occur, especially for older patients who put a patch on Monday, then forget on Wednesday and put another one on. Although I would think they would solve this problem with packaging.

And discarded patches seem to be a problem as well. Here’s an article I found from the Toronto Star from 8/7/07. It only discusses Canadian problems, but I’m sure they are applicable in the US.

Skin Patches Have Their Downside by Nancy J. White.

Morag Dickie liked the convenience. She could just slap the nitroglycerin patch onto her body in the morning and not worry about popping pills.

“I could feel a consistent flow of energy,” says Toronto resident Dickie, 55, a heart patient.

That’s the idea behind a skin patch – an easy-to-use method with smooth, controlled drug release, not the peaks and valleys of ingested medicine. In the U.S. last month, the Food and Drug Administration approved the first skin patch to treat Alzheimer’s disease. In May, it gave the green light to a drug patch for Parkinson’s disease. Last year, medicinal patches were approved Attention Deficit Hyperactivity Disorder and depression.

Researchers are developing an insulin patch for diabetics.

But it’s also a system that can present problems from the occasional skin irritation – the reason Dickie, who has sensitive skin, had to eventually give up her patch – to unintended poisonings. Three people in this country have died from use of the narcotic fentanyl patch, according to the Institute for Safe Medication Practices Canada (ISMPC).

In June, a federal jury in the U.S. awarded $5.5 million to the father of a 28-year-old man who died in 2003 while wearing a fentanyl patch for chronic hip pain after a car accident.

In Canada, prescription patches are approved for a handful of uses, including contraception and hormone replacement therapy, pain relief, smoking cessation, prevention of motion sickness and control of angina.

As for new ones, Health Canada does not disclose drugs it is reviewing, according to a spokesman. The patch to treat the dementia of Alzheimer’s has been submitted to Health Canada and the manufacturer hopes for approval next year, says Jason Jacobs, a spokesman for Novartis Pharmaceuticals Canada. That patch delivers the drug Exelon or rivastigmine, which is currently sold in Canada for oral use.

Patches provide a smoother delivery of drugs than tablets, which send medication for absorption to the intestine, and may lessen the potential for side effects by avoiding a high peak.

They are longer-acting, some up to a week. “There’s better compliance when the patient doesn’t have to worry about taking a medicine three or four times a day,” says Bill Wilson, pharmacy director at Mount Sinai Hospital.

Patients may, however, forget they’re wearing a patch, especially since some are clear. “We’ve had reports of more than one patch of the same drug put on a person,” says Sylvia Hyland, vice president of the non-profit group ISMPC.

Youngsters have been poisoned by chewing ondiscarded patches or putting them on. “Children are fascinated by stickers and bandages,” says Hyland. “A thrown-away patch still has some drug in it.”

The ISMP has had reports from emergency room staff concerned by unlabelled patches. And the most dangerous are the patches delivering fentanyl, a narcotic. “They need to be prescribed appropriately for chronic severe pain, not acute pain,” explains Hyland. “Physicians need to be very knowledgeable about the patch.”

Two of the Canadian deaths from the fentanyl patch were adolescents. The deaths occurred in 2004. It’s supposed to be only for adults, says Hyland.

The birth-control patch, EVRA, has also raised concerns after a study indicated women using it in the U.S. had an increased risk of blood clots in the legs and lungs than women on an oral contraceptive. Another study, however, showed no difference in the risk.