World’s First Donepezil Patch Commercialized
World’s First Donepezil Patch Commercialized
  • Bong Young Choi
  • 승인 2021.11.05 18:49
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Approved first in South Korea
Ideal alternative to oral formulation
아이큐어
 Icure

On November 5th, the Ministry of Food and Drug Safety of South Korea approved the Icure’s ‘Donepezil Transdermal Patch’, about seven months after applying for permission in April. With this approval, Icure won the title of the world's first successful commercialization of donepezil patch.

Icure, a South Korea-based biopharmaceutical company, developed ‘Donepezil Transdermal Patch’ using its novel ‘Transdermal Drug Delivery Technology’ which enables successful drug delivery as a form of transdermal patch. 

Donepezil is the most commonly prescribed medication for the treatment of Alzheimer’s dementia for the longest period of time among FDA-approved Alzheimer's drugs. However, donepezil has been commercialized only for oral use (tablet and thin film) due to technical difficulties in developing other formulations. Moreover, oral donepezil frequently induces gastrointestinal adverse effects such as nausea, vomiting, and diarrhea, leading to poor compliance and discontinuation of medication.

Considering the advantages of transdermal drug delivery including reduced dosing frequency, less side effects, improved bioavailability, and improved patient compliance compared to oral tablet, transdermal patch would be an ideal alternative to oral formulations and is expected to significantly improve the quality of life of patients.

Icure has successfully completed phase 3 clinical trials of donepezil patch (twice a week) in about 400 patients with mild and moderate Alzheimer’s dementia in four countries, including South Korea, Taiwan, Australia, and Malaysia. In particular, non-inferiority to oral donepezil was proved in patients with mild and moderate Alzheimer's dementia, when measured with the ADAS-cog (Alzheimer's Disease Assessment Scale Cognitive Subscale) evaluation.

Donepezil patch will be on the market around the second half of next year, after negotiations on drug price for national health insurance coverage.

In the case of rivastigmine (another cholinesterase inhibitor) patch released earlier than donepezil patch, it replaced 50% of oral agents in two years and 90% of them in five years after its launch. Expectations are high on how much donepezil patch will replace the market dominated by existing oral drugs.

Icure is also speeding up its entry into the global market following the success of domestic commercialization. “Phase 1 clinical trial in the U.S. was already approved by the FDA in April and is going to start in the second half of 2022.” announced Icure.



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