Oral donepezil has demonstrated statistically significant benefits in cognitive and functional performance1

Mild to Moderate Alzheimer’s Disease

Severe Alzheimer’s Disease

The efficacy of ADLARITY is based on the well-established efficacy profile of oral donepezil tablets.1

  • ADLARITY was FDA approved under Section 505(b)(2) of the Food, Drug, and Cosmetic Act based on a relative bioavailability study in healthy volunteers that compared ADLARITY with Aricept® (donepezil hydrochloride) tablets1,2

ADAS-cog
CIBIC-plus

In a 30-week study of 473 patients with mild to moderate Alzheimer’s disease1,a

Significant improvement in cognitive function1,3

Oral donepezil 5 mg/d and 10 mg/d demonstrated a statistically significant improvement in the mean difference in ADAS-cog scores vs placebo (P<.0001) at Week 24.

Time course of the change from baseline in ADAS-cog scores for patients completing 24 weeks of treatment1,3

Graph displaying oral donepezil showed clinical improvement in ADAS-cog scores. Graph displaying oral donepezil showed clinical improvement in ADAS-cog scores.
Graph displaying oral donepezil showed clinical improvement in ADAS-cog scores.
Graph displaying oral donepezil showed clinical improvement in ADAS-cog scores. Graph displaying oral donepezil showed clinical improvement in ADAS-cog scores.
  • The mean difference vs placebo in ADAS-cog change scores was 3.1 points for oral donepezil 10 mg/d and 2.8 points for oral donepezil 5 mg/d1
Graph displaying oral donepezil showed clinical improvement in ADAS-cog scores.
View CIBIC-plus

aStudy design: A randomized, double-blind, placebo-controlled study of donepezil tablets. Patients were randomized to receive single daily doses of placebo or either 5 mg or 10 mg of donepezil tablets for 24 weeks, followed by a 6-week, single-blind, placebo-washout period. The 10-mg/d treatment was started following an initial 7-day treatment with 5-mg/d doses. There was no statistically significant difference between the 2 active treatments.1

In a 30-week study of 473 patients with mild to moderate Alzheimer’s disease1,a

Significant difference in global functioning1,3

Oral donepezil 5 mg/d and 10 mg/d demonstrated a statistically significant improvement in the mean difference in CIBIC-plus scores vs placebo (P=.0047 and P<.0001, respectively) at Week 24.

Mean change from baseline in CIBIC-plus scores for patients completing 24 weeks of treatment3

Graph displaying mean changes from baseline in CIBIC-plus scores in patients completing 24 weeks of treatment. Graph displaying mean changes from baseline in CIBIC-plus scores in patients completing 24 weeks of treatment.
Graph displaying mean changes from baseline in CIBIC-plus scores in patients completing 24 weeks of treatment.
Graph displaying mean changes from baseline in CIBIC-plus scores in patients completing 24 weeks of treatment. Graph displaying mean changes from baseline in CIBIC-plus scores in patients completing 24 weeks of treatment.
  • The mean difference vs placebo in CIBIC-plus scores was 0.39 points for oral donepezil 10 mg/d and 0.35 points for oral donepezil 5 mg/d1
Graph displaying mean changes from baseline in CIBIC-plus scores in patients completing 24 weeks of treatment.
View ADAS-cog

aStudy design: A randomized, double-blind, placebo-controlled study of donepezil tablets. Patients were randomized to receive single daily doses of placebo or either 5 mg or 10 mg of donepezil tablets for 24 weeks, followed by a 6-week, single-blind, placebo-washout period. The 10-mg/d treatment was started following an initial 7-day treatment with 5-mg/d doses. There was no statistically significant difference between the 2 active treatments.1

ADCS-ADL-Severe
SIB

In a 6-month study of 248 patients with severe Alzheimer’s disease1,b

Significant difference in ADL and global functioning1,4,c

Oral donepezil 10 mg/d demonstrated statistical significance in the mean difference in ADCS-ADL-Severe scores vs placebo (P=.03).

Time course of the change from baseline in ADCS-ADL-Severe scores for patients completing 6 months of treatment1,4

Graph displaying oral donepezil demonstrated a significant difference in ADLs and global functioning.
Graph displaying oral donepezil demonstrated a significant difference in ADLs and global functioning.
Graph displaying oral donepezil demonstrated a significant difference in ADLs and global functioning.
  • The mean difference vs placebo in ADCS-ADL-Severe change scores was 1.8 points1
Graph displaying oral donepezil demonstrated a significant difference in ADLs and global functioning.
View SIB

bStudy design: A 6-month, randomized, double-blind, placebo-controlled study conducted in Sweden in 248 patients with severe Alzheimer’s disease. Patients were randomized to receive single daily doses of placebo or oral donepezil tablets. For patients who were randomized to donepezil, treatment was initiated at 5 mg/d for 28 days and then increased to 10 mg/d. At the end of the 6-month treatment period, 90.5% of the donepezil-treated patients were receiving the 10-mg/d dose.1

cFunctional assessment (ADCS-ADL-Severe) through caregiver-rated assessment.1

In a 6-month study of 248 patients with severe Alzheimer’s disease1,b

Significant difference in cognitive function1,4

Time course of the change from baseline in SIB scores for patients completing 6 months of treatment1,4

Oral donepezil showed clinical improvement in SIB scores.
Oral donepezil showed clinical improvement in SIB scores.
Oral donepezil showed clinical improvement in SIB scores.
  • The mean difference vs placebo in SIB change scores for patients taking oral donepezil 10 mg/d was 5.9 points (P=.008)1,4
Oral donepezil showed clinical improvement in SIB scores.
View ADCS-ADL-Severe

bStudy design: A 6-month, randomized, double-blind, placebo-controlled study conducted in Sweden in 248 patients with severe Alzheimer’s disease. Patients were randomized to receive single daily doses of placebo or oral donepezil tablets. For patients who were randomized to donepezil, treatment was initiated at 5 mg/d for 28 days and then increased to 10 mg/d. At the end of the 6-month treatment period, 90.5% of the donepezil-treated patients were receiving the 10-mg/d dose.1

ADAS-cog, Alzheimer’s Disease Assessment Scale-Cognitive Subscale; ADCS-ADL-Severe, Alzheimer’s Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer’s Disease; ADL, activities of daily living; CIBIC-plus, Clinician’s Interview-Based Impression of Change with caregiver input; FDA, US Food and Drug Administration; HCl, hydrochloride; SIB, Severe Impairment Battery.

INDICATION

ADLARITY is indicated for the treatment of mild, moderate, and severe dementia of the Alzheimer's type.

IMPORTANT SAFETY INFORMATION

Contraindications

ADLARITY is contraindicated in patients with known hypersensitivity to donepezil or to piperidine derivatives or with a history of allergic dermatitis with use of ADLARITY.

INDICATION

ADLARITY is indicated for the treatment of mild, moderate, and severe dementia of the Alzheimer's type.

IMPORTANT SAFETY INFORMATION

Contraindications

ADLARITY is contraindicated in patients with known hypersensitivity to donepezil or to piperidine derivatives or with a history of allergic dermatitis with use of ADLARITY.

Warnings and Precautions
  • Application site skin reactions: ADLARITY may cause skin application-site reactions. These reactions are not necessarily indicative of sensitization; however, allergic contact dermatitis may occur and should be suspected if application-site reactions spread beyond the size of the transdermal system, there is evidence of a more intense local reaction, and symptoms do not significantly improve within 48 hours of transdermal system removal.
  • Anesthesia: ADLARITY, as a cholinesterase inhibitor, is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia.
  • Cardiovascular conditions: Cholinesterase inhibitors, including ADLARITY, may have vagotonic effects on the sinoatrial and atrioventricular nodes. These effects may manifest as bradycardia or heart block in patients both with and without known underlying cardiac conduction abnormalities. Syncopal episodes have been reported in association with the use of donepezil.
  • Nausea and vomiting: Donepezil, the active ingredient in ADLARITY, may cause diarrhea, nausea, and vomiting. In most cases these effects have been transient, although some cases lasted 1 to 3 weeks. Patients should be monitored closely during initiation of treatment and after dose increases.
  • Peptic ulcer disease and gastrointestinal bleeding: Cholinesterase inhibitors, including ADLARITY, may increase gastric acid secretion. Patients should be monitored closely for active or occult gastrointestinal bleeding, especially those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs).
  • Genitourinary conditions: Although not observed in clinical trials of ADLARITY, bladder outflow obstruction may occur.
  • Seizures: Cholinomimetics, including ADLARITY, are believed to have some potential to cause generalized convulsions; however, seizure activity may also be a manifestation of Alzheimer's disease.
  • Pulmonary conditions: Cholinesterase inhibitors, including ADLARITY, should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.
Adverse Reactions

The most common adverse reactions (greater than 5% with donepezil tablets and twice the placebo rate) are nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and anorexia.

Drug Interactions

Cholinesterase inhibitors, including donepezil, have the potential to interfere with the activity of anticholinergic medications. A synergistic effect may be expected when cholinesterase inhibitors are given concurrently with succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists such as bethanechol.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/MedWatch or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information.

References: 1. ADLARITY. Prescribing information. Corium, LLC; 2022. 2. Center for Drug Evaluation and Research. Adlarity (donepezil transdermal system) NDA approval. US Food and Drug Administration. Accessed January 20, 2023. https://www.accessdata.fda.gov/
drugsatfda_docs/
appletter/2022/212304Orig1s000ltr.pdf 3. Rogers SL, Farlow MR, Doody RS, Mohs R, Friedhoff LT; the Donepezil Study Group. A 24-week, double-blind, placebo-controlled trial of donepezil in patients with Alzheimer’s disease. Neurology. 1998;50(1):136-145. doi:10.1212/wnl.50.1.136 4. Winblad B, Kilander L, Eriksson S, et al; for the Severe Alzheimer’s Disease Study Group. Donepezil in patients with severe Alzheimer’s disease: double-blind, parallel-group, placebo-controlled study. Lancet. 2006;367(9516):1057-1065. doi:10.1016/S0140-6736(06)68350-5