FDA Approves Weekly Skin Patch to Treat Dementia

Last month, the Food and Drug Administration (FDA) approved biopharmaceutical company Corium’s Adlarity (donepezil transdermal system) to treat mild, moderate, or severe Alzheimer’s-related dementia. The drug is the first patch available for dementia and works to deliver a consistent dose of donepezil through the skin.

The approval comes after the FDA reviewed clinical trial data showing the transdermal drug works just as well as its oral counterpart.

“The FDA approval of Adlarity brings to market a new and innovative way to deliver consistently a well-tolerated form of donepezil, the most widely used medicine for patients with Alzheimer’s disease,” Perry J. Sternberg, president and CEO of Corium, said in a press release.

James Giordano, PhD, MPhil, a professor in the departments of neurology and biochemistry at Georgetown University, told Verywell that the drug is a welcome addition to the toolkit for treating Alzheimer’s dementia. He said it will make treatments more accessible and, in turn, more effective.

“When you have more effective medication for the patient, particularly during the early and mid-stages of Alzheimer’s, we characteristically get better outcomes,” Giordano said.

Adlarity is a patch you wear for seven days before replacing it with another. It will be available with a prescription from a healthcare provider when it becomes available in early fall 2022. The treatment is approved in 5 mg/day or 10 mg/day dosages. You can place the patch on your back, upper buttock, or upper thigh.

What to Know About Adlarity

Adlarity tackles a problem that has been an issue for other dementia treatments: remembering to take your medicine. Short-term memory is one of the first symptoms of Alzheimer’s disease that begins to worsen.

Giordano said there are plenty of ways you can remind people to take their medication—from setting an alarm clock on the phone to having a caregiver. However, if a person wants to be relatively independent, he said they may commonly forget to take the drug or forget when they took it. “Remembering an hour or two later can lead to drug levels dropping or [fluctuating] which can be important,” Giordano added.

With Adlarity a person will not have to remember to take the drug as often. Giordano said it is also more realistic for a person with Alzheimer’s to remember to put a patch on or take it off every seven days than having to remember to take a drug every day.

While donepezil is available in tablet form (Aricept), Giordano said having a transdermal route provides a steadier dose delivery over a longer period of time. When you take a drug by mouth, the drug does not take effect immediately because it has to go from the gastrointestinal tract into the bloodstream before its effects reach the brain.

However, with oral drugs, you get a peak effect when the drug kicks in, and then an end of dosing phenomenon when the drug dose tapers off, which causes the drug to lose its effect. But with a skin patch, you get a steady release of the drug, keeping it from eventually wearing off.

“The patch is usually worn in a way that allows it to be replaced within one to two half-lives of the drug,” Giordano explained. “So not only are you keeping the drug at a steady state, but you’re also maintaining the effect of the drug on the neural chemical system it’s targeting.”

How Do People Take Adlarity?

You can talk to your healthcare provider about whether you’d be a good candidate for Adlarity, and if so, they will write you a prescription for it. You will start off with 5 mg/day of the drug but after four to six weeks, your doctor may increase your dosage to 10 mg/day if needed. If you’re already taking donepezil tablets, you can easily switch to the patch since both drugs are available in 5 mg and 10 mg doses.

Adlarity is a once-weekly patch that uses one patch to deliver a consistent drug dose. “There are patients who think that one patch works great so they will slap on another and see if it works better,” Giordano said. “But that does not help. The patch itself is dosed and should be used exactly as prescribed.”

If you miss a dose or the patch falls off, the FDA recommends placing a new patch right away and then starting the one-week cycle seven days after you applied the new patch.

The FDA recommends placing the patch on the back to avoid the spine. You may also have the patch placed on the upper buttocks or the upper outer thigh. The patch can work by itself and does not need to be taken in combination with another drug.

Accessibility and Limitations of Adlarity

Giordano noted that all the same precautions and contraindications for donepezil tablets apply to the patch. People who do not qualify for Adlarity include:

• Anyone taking other medications that target the cholinergic system
• A person with a history of being hypersensitive to donepezil or piperidine derivatives 

A person who is pregnant or who plans to be pregnant should avoid using Adlarity for risk of harm to the fetus. While there is not sufficient data on Adlarity’s developmental risks, one animal study found that pregnant rats given donepezil (at a dose higher than the recommended human dose) showed signs of minimal maternal toxicity.

Additionally, it's important to let your healthcare provider know if you take high blood pressure medication, as this can factor into their decision whether to prescribe Adlarity.

The FDA stated that people with a history of asthma or obstructive pulmonary disease should be prescribed Adlarity with caution. Further, people taking Adlarity who are going under anesthesia are likely to experience stronger muscle relaxation.

Known Side Effects 

Adlarity can cause several side effects including:

• Allergic contact dermatitis 
• Nausea and vomiting
• Heart conditions such as bradycardia or heart block
• Gastrointestinal bleeding, especially in people with an increased risk of ulcers
• Blockage in the bladder that makes it difficult to pass urine
• Seizures
• Muscle cramps
• Fatigue
• Anorexia
• Worsening lung problems in people who have asthma or a lung disease

If you have any of the following side effects while using Adlarity, contact your healthcare provider.