Corium’s Adlarity (donepezil hydrochloride) has recently received FDA approval as a treatment for patients with mild, moderate, or severe dementia of Alzheimer’s disease (AD).  However, as Adlarity is the fourth cholinesterase inhibitor product to launch in the US market, it enters a fiercely competitive space for the symptomatic treatment of AD finds GlobalData.

According to the leading data and analytics company, the cholinesterase inhibitors, including Adlarity, are forecast to contribute a combined $895.9 million to the US AD market by 2030.

Adlarity consists of a single patch that is placed by the patient or caregiver on the patient’s back, thigh, or buttocks. Its once-weekly application will set it apart from other cholinesterase products with more frequent daily oral or transdermal dosing.

Christie Wong, Pharma Analyst at GlobalData comments: “This is not only ideal for patients who have difficulty swallowing tablets, but the dosing schedule will also help with compliance and make treatment easier for patients and caregivers. Furthermore, the transdermal route of administration reduces the likelihood of the adverse gastrointestinal side effects that are often associated with oral donepezil. GlobalData forecasts that Adlarity will reach sales of $203 million in the US by 2030.”

Donepezil is the most commonly prescribed medication in a class of AD drugs known as the cholinesterase inhibitors and is considered the gold standard symptomatic treatment for AD. They inactivate chlolinesterases and inhibit the hydrolysis of acetylcholine. This leads to an increase in the concentration of acetylcholine in synapses, which can enhance cholinergic neurotransmission in the brain.

Despite being the first transdermal patch formulation of donepezil available in the US, Adlarity’s uptake is expected to be moderate. Adlarity will be competing with Eisai and Pfizer’s Aricept and generic versions of oral donepezil, which dominate the market. Adlarity is also expected to face tough competition from other marketed cholinesterase inhibitors, many of which have also experienced generic erosion and are likely to have lower annual costs when compared to Adlarity. These include Novartis’ Exelon (rivastigmine), a non-specific cholinesterase inhibitor that is available in both once-daily oral* or transdermal formulations; Johnson & Johnson’s Razadyne (galantamine), a cholinesterase inhibitor that also enhances the intrinsic action of acetylcholine on nicotinic receptors; and AbbVie’s Namzaric, which is a single pill that combines donepezil with memantine XR.

Wong concludes: “Unfortunately, cholinesterase inhibitors only provide symptomatic relief, and do not treat the underlying cause of AD. Although disease-modifying therapies are still in early development, potential remains in the future for the use of combination treatment regimens pairing cholinesterase inhibitors with disease-modifying products. This type of regimen may be made even more feasible for patients due to the availability of a once weekly donepezil product like Adlarity.”

*The oral form of branded Exelon has been withdrawn from the market, however generic forms of oral rivastigmine are still available.