Manufacturing and Marketing Approval Received in Japan for ALLYDONE® Patches for Treatment of Dementia Due to Alzheimer’s Disease as Japan’s First Donepezil Transdermal Therapeutic System
Teikoku Seiyaku Co., Ltd. (Head Office: Higashikagawa City, Kagawa, Japan) and Kowa Company, Ltd. (Head Office: Nagoya City, Aichi, Japan) have announced that on December 23, 2022, Teikoku Seiyaku has acquired manufacturing and marketing approval for ALLYDONE® Patches 27.5 mg / ALLYDONE® Patches 55 mg（hereinafter referred to as ALLYDONE® Patches；tape formulations）for the treatment of dementia due to Alzheimer’s disease. ALLYDONE® Patches are indicated for the suppression of progression of dementia symptoms in dementia due to Alzheimer’s disease by the Ministry of Health, Labour and Welfare.
These tape formulations are Japan’s first transdermal therapeutic system containing donepezil as an active pharmaceutical ingredient. Donepezil suppresses progression of cognitive decline associated with dementia due to Alzheimer’s disease. This is due to the activation of cholinergic neurons through the elevation of the brain’s acetylcholine levels by inhibiting acetylcholinesterase, an acetylcholine degrading enzyme contained in the nervous system.
In April 2022, Teikoku Seiyaku and Kowa reached an Exclusive Distribution Agreement for sales of ALLYDONE® Patches. Teikoku Seiyaku will supply the product to Kowa, and Kowa will distribute and market it.
Teikoku Seiyaku and Kowa would like to contribute to the welfare of more patients, care givers and healthcare providers by providing these tape formulations as a new treatment option for dementia due to Alzheimer’s disease.
For further information, please contact:
Teikoku Seiyaku Co., Ltd. General Affairs Department
TEL：+81-3-3661-3331
Overview of ALLYDONE® Patches 27.5 mg / ALLYDONE® Patches 55 mg
| Product names | ALLYDONE® Patches 27.5 mg / ALLYDONE® Patches 55 mg |
|---|---|
| Generic name | Donepezil |
| Indications | Suppression of progression of dementia symptoms in dementia due to Alzheimer’s disease |
| Dosage and Administration | The dosage for patients with mild to moderate dementia due to Alzheimer's disease is 27.5 mg once daily. The dosage for patients with severe dementia due to Alzheimer's disease, is increased to 55 mg after at least 4 weeks at 27.5 mg. The dose may be reduced to 27.5 mg once daily according to patients' symptoms. Apply to the affected area (normal and healthy skin on back, upper arms and upper chest) and change every 24 hours. |