Safety profile of ADLARITY®1
In a Phase 1 study in healthy volunteers, the types of adverse events were consistent between ADLARITY and oral donepezil1
Most common adverse reactions (incidence >3%) occurring in healthy volunteers
receiving ADLARITY 10 mg/d (n=60)
| Headache | 15% |
|---|---|
| Application site pruritus | 9% |
| Muscle spasms | 9% |
| Insomnia | 7% |
| Abdominal pain | 6% |
| Application site dermatitis | 6% |
| Constipation | 6% |
| Diarrhea | 4% |
| Application site pain | 4% |
| Dizziness | 4% |
| Abnormal dreams | 4% |
| Skin laceration | 4% |
Incidences of skin irritation with ADLARITY were mild1,a
-
Skin irritation observed 30 minutes after removal of ADLARITY 10 mg/d (n=268) included erythema (64.6%),
papules (16.0%), and edema (0.4%)1,2 - 99.6% of observed incidences of skin irritation were rated as ≤3 in Dermal Response Score2,b
- No transdermal system was removed due to skin irritation2
No individuals discontinued ADLARITY treatment due to TEAEs in this study2
An open-label study in 60 healthy volunteers who received ADLARITY 5 mg/d for 5 weeks in Period 1 as a titration dose. In Periods 2 and 3, the volunteers received either ADLARITY 10 mg/d for 5 weeks or oral donepezil 10 mg/d tablets for 5 weeks in a randomized, crossover fashion.1
Skin tolerability was assessed by Dermal Response Scores (range, 0-7), defined as 0=no evidence of irritation; 1=minimal erythema that is barely perceptible; 2=definite erythema that is readily visible and minimal edema, or minimal papular response; 3=erythema and papules; 4=definite edema; 5=erythema, edema, and papules; 6=vesicular eruption; and 7=strong reaction spreading beyond the application site. Among incidences of skin irritation observed, 19.0% were rated as 1, 64.6% were rated as 2, 16.0% were rated as 3, and 0.4% were rated as 5.2
TEAE, treatment-emergent adverse event.
