Post by alice on May 3, 2022 8:13:44 GMT -5
FDA Approves Weekly Patch to Treat Alzheimer's-Related Dementia
FDA Approves Weekly Patch to Treat Alzheimer's-Related Dementia
The treatment is not the first skin patch to help manage the disease—but it is the first once-weekly version.
By Mariana LenharoApril 13, 2022
Fact checked on April 13, 2022 by Rich Scherr, a journalist and fact-checker with more than three decades of experience.
The U.S. Food and Drug Administration (FDA) has approved a weekly skin patch used to treat symptoms of Alzheimer's-related dementia. The treatment is a patch formulation of the oral drug donepezil (Aricept), which has been available for many years and is one of the most commonly prescribed drugs for patients with Alzheimer's disease.
The new medication, which will be sold under the brand name Adlarity, is not the first skin patch approved for Alzheimer's disease, but it is the first to be administered once weekly. This regimen is expected to benefit certain patients.
"It would be better for forgetful patients who have to remember taking their medications or patients who have paranoia and refuse to take medications, for example," neurologist Riddhi Patira, MD, an assistant professor and investigator at the University of Pittsburgh Alzheimer's Disease Research Center, told Health.
Another advantage of the patch is the potential for fewer side effects. According to Dr. Patira, the most common adverse reactions to the oral donepezil are gastrointestinal problems, such as nausea and diarrhea. Those should not be completely eliminated, as they are directly caused by the drug's mechanism of action, she said. But they will likely be less severe with the skin patch, compared to the oral formulation.
RELATED: Black Patients Are Less Likely to Receive a Timely Dementia Diagnosis, Despite Having the Highest Risk
HOW IT WORKS
Adlarity can be placed directly on a patient's back, thigh, or buttocks, according to a press release from Corium, Inc., the drug's maker. The once-weekly patch delivers a continuous and consistent dose of donepezil through the skin.
Once in the body, the transdermal version of donepezil works similarly to the oral formulation of the drug. "What donepezil does, as I frequently tell patients and their families, is that it works to keep the acetylcholine—a molecule that we all have in our brains—longer to help with attention and memory," geriatrician Mia Yang, MD, an assistant professor with Atrium Health Wake Forest Baptist in North Carolina, and a researcher in the Wake Forest Alzheimer's Disease Research Center, told Health. "But certainly, it is not a cure for Alzheimer's disease or other types of dementia."
Acetylcholine is a neurotransmitter that plays an important role in memory and thinking. Patients with Alzheimer's disease usually have less of that molecule than normal. As a cholinesterase inhibitor, donepezil works by inhibiting cholinesterase, an enzyme that breaks down acetylcholine, aiming to preserve the patient's level of this neurotransmitter.
Because donepezil doesn't target anything specific to Alzheimer's disease (we all have acetylcholine in our brains), it is expected to work for other types of dementia as well. The only exception is frontotemporal dementia (FTD). "Donepezil has been studied in double-blinded, randomized clinical trials in FTD patients and it doesn't help, it actually worsens the behavior," Dr. Patira said. "And this is pretty important because, when my patients come to me, sometimes they don't have a specific diagnosis, they are just labeled as dementia."
DRUG AVAILABILITY
According to Corium, Inc., the new patch will be commercially available in early fall 2022. But doctors are skeptical that the new product will be covered by health insurance, based on previous experiences.
Rivastigmine (Exelon) is a medication of the same class as donepezil that is already available as a skin patch (the difference is that it has a once-daily, instead of once-weekly, regimen). "Usually, it's rather hard to get people approved from their insurance company to get the rivastigmine patch," said Dr. Yang.
According to Dr. Yang, she normally has to document that the patient had side effects from the oral version of rivastigmine to justify the request for the patch version. Dr. Patira has had a similar experience. "Getting the rivastigmine patch has been a battle with insurance companies," she said.
FDA Approves Weekly Patch to Treat Alzheimer's-Related Dementia
The treatment is not the first skin patch to help manage the disease—but it is the first once-weekly version.
By Mariana LenharoApril 13, 2022
Fact checked on April 13, 2022 by Rich Scherr, a journalist and fact-checker with more than three decades of experience.
The U.S. Food and Drug Administration (FDA) has approved a weekly skin patch used to treat symptoms of Alzheimer's-related dementia. The treatment is a patch formulation of the oral drug donepezil (Aricept), which has been available for many years and is one of the most commonly prescribed drugs for patients with Alzheimer's disease.
The new medication, which will be sold under the brand name Adlarity, is not the first skin patch approved for Alzheimer's disease, but it is the first to be administered once weekly. This regimen is expected to benefit certain patients.
"It would be better for forgetful patients who have to remember taking their medications or patients who have paranoia and refuse to take medications, for example," neurologist Riddhi Patira, MD, an assistant professor and investigator at the University of Pittsburgh Alzheimer's Disease Research Center, told Health.
Another advantage of the patch is the potential for fewer side effects. According to Dr. Patira, the most common adverse reactions to the oral donepezil are gastrointestinal problems, such as nausea and diarrhea. Those should not be completely eliminated, as they are directly caused by the drug's mechanism of action, she said. But they will likely be less severe with the skin patch, compared to the oral formulation.
RELATED: Black Patients Are Less Likely to Receive a Timely Dementia Diagnosis, Despite Having the Highest Risk
HOW IT WORKS
Adlarity can be placed directly on a patient's back, thigh, or buttocks, according to a press release from Corium, Inc., the drug's maker. The once-weekly patch delivers a continuous and consistent dose of donepezil through the skin.
Once in the body, the transdermal version of donepezil works similarly to the oral formulation of the drug. "What donepezil does, as I frequently tell patients and their families, is that it works to keep the acetylcholine—a molecule that we all have in our brains—longer to help with attention and memory," geriatrician Mia Yang, MD, an assistant professor with Atrium Health Wake Forest Baptist in North Carolina, and a researcher in the Wake Forest Alzheimer's Disease Research Center, told Health. "But certainly, it is not a cure for Alzheimer's disease or other types of dementia."
Acetylcholine is a neurotransmitter that plays an important role in memory and thinking. Patients with Alzheimer's disease usually have less of that molecule than normal. As a cholinesterase inhibitor, donepezil works by inhibiting cholinesterase, an enzyme that breaks down acetylcholine, aiming to preserve the patient's level of this neurotransmitter.
Because donepezil doesn't target anything specific to Alzheimer's disease (we all have acetylcholine in our brains), it is expected to work for other types of dementia as well. The only exception is frontotemporal dementia (FTD). "Donepezil has been studied in double-blinded, randomized clinical trials in FTD patients and it doesn't help, it actually worsens the behavior," Dr. Patira said. "And this is pretty important because, when my patients come to me, sometimes they don't have a specific diagnosis, they are just labeled as dementia."
DRUG AVAILABILITY
According to Corium, Inc., the new patch will be commercially available in early fall 2022. But doctors are skeptical that the new product will be covered by health insurance, based on previous experiences.
Rivastigmine (Exelon) is a medication of the same class as donepezil that is already available as a skin patch (the difference is that it has a once-daily, instead of once-weekly, regimen). "Usually, it's rather hard to get people approved from their insurance company to get the rivastigmine patch," said Dr. Yang.
According to Dr. Yang, she normally has to document that the patient had side effects from the oral version of rivastigmine to justify the request for the patch version. Dr. Patira has had a similar experience. "Getting the rivastigmine patch has been a battle with insurance companies," she said.
I am no longer able to hold your hand my beloved but I cherish the remembrance of your hand in mine...and the wonderful person that touched so many lives with joy. : )