FDA Approves Donepezil Patches to Treat Alzheimer’s-Related Dementia

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FDA Approves Donepezil Patches to Treat Alzheimer’s-Related Dementia

Written by Joshua Murdock, PharmD | Reviewed by Alyssa Billingsley, PharmD Published on March 17, 2022

Key takeaways:

  • In March 2022, the FDA approved Adlarity (donepezil transdermal system) to treat Alzheimer’s-related dementia.
  • Adlarity is a once-weekly patch that’s applied to your skin. Patches are often helpful if you can’t swallow pills or if pills cause bothersome side effects. 
  • We don’t know exactly when Adlarity will be available to the public, but it’s expected to be available in the U.S. come early fall 2022. 
Older man in glasses and a sweater sitting in a living room chair looking out the window.

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Alzheimer’s disease is complicated. The symptoms that it can cause are often life-changing. Most FDA-approved medications for Alzheimer’s disease are used to help manage these symptoms. And researchers are exploring ways to slow down progression of the disease itself. The good news is advances in Alzheimer’s research are starting to change what it means to live with Alzheimer’s. 

One of these steps forward happened this month. In March 2022, the FDA approved Adlarity (donepezil transdermal system), a new treatment option for Alzheimer’s-related dementia. This news comes after the FDA approved another new Alzheimer’s medication in June 2021.

If Adlarity’s generic name — donepezil — sounds familiar, you’re right. Donepezil (Aricept) tablets have been available in the U.S. for decades. But given how Alzheimer’s can affect the body, oral tablets aren’t always ideal, or realistic, options. Patches that are applied to the skin, like Adlarity, can help make you or your loved one’s medication routine a little bit easier. 

Here, we’ll look at Adlarity — what it is, how it works, and how it compares to the oral version 

What is Adlarity?

Adlarity is a patch formulation of donepezil that’s applied to your skin. It’s FDA-approved to treat mild, moderate, and severe forms of Alzheimer’s-related dementia. It’s available as a brand-name product.

Alzheimer’s-related dementia is the most common form of dementia. But dementia can also be caused by other health conditions, like Huntington’s disease, Parkinson’s disease, and Creutzfeldt-Jakob disease. Adlarity can treat Alzheimer’s-related dementia, but it’s not approved to treat other types of dementia.

Adlarity is made by Corium, Inc, a Michigan-based pharmaceutical company. 

How does Adlarity work to treat Alzheimer’s disease?

Donepezil is an acetylcholinesterase inhibitor. It works by stopping the activity of an enzyme (protein) in your body called acetylcholinesterase. But what does this mean? 

Let’s use an example. It’s hard to grow a forest if there’s always someone there who’s chopping down trees. But by taking away the person’s axe, trees will be left alone to grow and thrive. More trees can lead to a healthier forest. 

In this example, acetylcholine is a tree. Acetylcholine is a chemical that’s found in your brain. It helps nerve cells communicate with each other. When acetylcholine isn’t as readily available, it’s harder for these cells to talk. In Alzheimer’s disease, there’s often less acetylcholine in the brain than normal.

Acetylcholinesterase is like the axe being used to chop down trees. Acetylcholinesterase’s main job is to break down acetylcholine, lowering the amount of it in your brain. 

Adlarity, then, is what disarms the person chopping trees. And in the brain, it stops acetylcholinesterase from working, allowing for there to be more acetylcholine. This can help improve certain Alzheimer’s symptoms.

How is Adlarity dosed?

Adlarity is a once-weekly patch. You put it on, wear it for 7 days, then replace it with a new one. 

It’s available in two strengths. The patches are designed to release either 5 mg or 10 mg of donepezil every day. Your healthcare provider can tell you which strength may be more ideal for you to start out with.

But if you already use donepezil tablets, it’s pretty easy to switch to Adlarity if needed. This is because the tablets are also available in 5 mg and 10 mg strengths, among others. You can directly switch to your equivalent dose of the patch. For instance, if you take donepezil 5 mg tablets every day, you can switch to the 5 mg weekly patch. Switching to a patch can be a more convenient option, especially if memory problems have made it hard to swallow pills.

You can apply Adlarity to the back, upper buttocks, or outer thigh. After you start using Adlarity, it’s important to remove the old patch before putting a new one on. Two patches should never be on your body at the same time. If you’re switching to Adlarity from donepezil tablets, your first patch is applied the same time as your last oral dose.

How effective is Adlarity?

Adlarity’s effectiveness is thought to be comparable to donepezil tablets. It doesn’t target Alzheimer’s underlying disease process, but it can help with certain symptoms. 

The two formulations were found to be bioequivalent in research that contributed to Adlarity’s approval. When two medications are bioequivalent, it generally means that they have the same therapeutic effect — they’re expected to achieve the same results in the body.

Bioequivalence is a common way to measure a medication’s usefulness. For example, when a new generic medication is approved by the FDA, bioequivalence studies are often analyzed to make sure the generic medication is comparable to the name-brand medication that it’s trying to copy. 

We discuss the effectiveness of donepezil tablets in another GoodRx Health article. 

What are the known side effects of Adlarity?

Adlarity has a number of possible side effects. Common side effects include:

  • Headache
  • Itchy or irritated skin where the patch was applied
  • Pain where the patch was applied
  • Muscle spasms
  • Insomnia
  • Abdominal pain
  • Constipation
  • Diarrhea
  • Dizziness
  • Abnormal dreams

Adlarity shares many of its common side effects with donepezil tablets. But compared to the tablets, Adlarity tends to cause fewer gastrointestinal (GI) side effects. This is because the tablets go through the stomach and intestines, but the patch is absorbed through the skin and directly into the bloodstream. 

Are there any serious side effects or risks to be aware of?

Although rare, a few serious side effects are also possible. Reach out to your healthcare provider right away if you’re experiencing — or think you’re experiencing — any of these side effects:

  • Very slow heart rate
  • Symptoms of a GI bleed
  • Seizures
  • A block in your bladder that doesn’t allow urine to flow
  • Worsening asthma or COPD symptoms 

Does Adlarity interact with other medications?

Thankfully, there aren’t too many interactions to be aware of. But one group of medications to look out for are anticholinergic medications. Adlarity may make the following medications less effective:

  • Benztropine
  • Dicyclomine
  • Diphenhydramine (Benadryl)
  • Glycopyrrolate (Cuvposa, Robinul)
  • Hyoscyamine (Levsin)
  • Oxybutynin
  • Scopolamine (Transderm Scop)
  • Trihexyphenidyl
  • Tolterodine (Detrol)

It may also make certain medications — such as succinylcholine — more plentiful in the body. This can be dangerous. This can cause problems for certain procedures using anesthesia. So if you use Adlarity, and are about to undergo a procedure with anesthesia, make sure your care team is aware that you use this medication.

This isn’t a full list of drug interactions. For more information, make sure to speak with your pharmacist. 

When will Adlarity be available?

Even though Adlarity is now approved, it’s not available quite yet. Adlarity is expected to be available sometime in early fall 2022. As this date gets closer, the manufacturer of the medication will likely share more information about its specific release date.

How much will Adlarity cost?

Adlarity’s cost hasn’t been announced yet. And since it won’t be available until later this year, we likely won’t know much about its list price until its release date gets closer. This also means that we don’t have much information yet about ways you can save. 

Make sure to check back with GoodRx for updates on Adlarity’s cost and ways to save. Savings opportunities with GoodRx and Adlarity’s manufacturer will likely be options. 

The bottom line

Adlarity (donepezil transdermal system) was FDA-approved in March 2022 for adults with Alzheimer’s-related dementia. It doesn’t target the root cause of dementia, but it can help treat certain symptoms. It’s a weekly-patch that’s expected to be available in the U.S. later this year. If you think Adlarity might be an option for you or a loved one, consider reaching out to your healthcare provider for more information.

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