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 and was FDA approved based on a relative bioavailability study in healthy volunteers.1,a

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

Significant improvement in cognitive function1,2

Oral donepezil 5 mg/d and 10 mg/d both 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 treatment1,2

Graph displaying Oral donepezil showed clinical improvement in ADAS-cog scores. Graph displaying Oral donepezil showed clinical improvement in ADAS-cog scores.
  • Mean difference vs placebo in ADAS-cog scores was 3.1 points for oral donepezil 10 mg/d and 2.8 points for oral donepezil 5 mg/d1
  • Oral donepezil HCl 10 mg/d (n=150)
  • Oral donepezil HCl 5 mg/d (n=152)
  • Placebo (n=153)

Improved ADAS-cog scores demonstrate delayed impairment in cognitive function, including memory, orientation, attention, language, reasoning, and praxis.1

  • Mean difference vs placebo in ADAS-cog scores was 3.1 points for oral donepezil 10 mg/d and 2.8 points for oral donepezil 5 mg/d1

Significant difference in global functioning1,2

Oral donepezil 5 mg/d and 10 mg/d both 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 in patients completing 24 weeks of treatment2

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.
  • 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
  • Oral donepezil HCl 10 mg/d (n=149)
  • Oral donepezil HCl 5 mg/d (n=149)
  • Placebo (n=152)

Improved CIBIC-plus scores demonstrate delayed impairment in 4 areas of patient function, including general, cognitive, behavioral, and ADLs.1

  • 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

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) tablets.1,3
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 6-month study of 248 patients with severe Alzheimer's disease1,c

Significant difference in ADLs and global functioning1,4,d

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.
  • Mean difference vs placebo in ADCS-ADL-Severe scores at 6 months was 1.8 points for oral donepezil 10 mg/d1
  • Oral donepezil HCl 10 mg/d (n=109)
  • Placebo (n=107)

ADCS-ADL-Severe scores demonstrate delayed impairment in activities such as patients' ability to eat, dress, bathe, use the telephone, get around, and perform other ADLs.1

  • Mean difference vs placebo in ADCS-ADL-Severe scores at 6 months was 1.8 points for oral donepezil 10 mg/d1

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.
  • Mean difference vs placebo in SIB scores at 6 months for patients taking oral donepezil 10 mg/d was 5.9 points (P=.008)1,4
  • Oral donepezil HCl 10 mg/d (n=109)
  • Placebo (n=107)

Improved SIB scores indicate delayed impairment in cognitive performance, including elements of memory, language, orientation, attention, praxis, visuospatial ability, construction, and social interaction.1

  • Mean difference vs placebo in SIB scores at 6 months for patients taking oral donepezil 10 mg/d was 5.9 points (P=.008)1,4

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

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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, activity 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.

References: 1. ADLARITY. Prescribing information. Corium, Inc; 2022. 2. 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 3. Center for Drug Evaluation and Research. Adlarity (donepezil transdermal system) NDA approval. US Food and Drug Administration. Accessed July 14, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/
appletter/2022/212304Orig1s000ltr.pdf 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