Corium (NSDQ:CORI) announced that studies support its once-weekly Adlarity transdermal treatment for Alzheimer’s dementia.
Adlarity (donepezil transdermal system) demonstrated the ability to maintain equivalent daily exposure of donepezil when compared to oral formulations of donepezil, along with a favorable overall gastrointestinal (GI) side effect profile.
The treatment uses Corium’s proprietary Corplex technology, delivering continuous, controlled, and sustained release of a drug over a defined time. It represents the first and only once-weekly transdermal formulation of donepezil approved by the FDA, with an indication for patients with mild, moderate, or severe dementia of the Alzheimer’s type in 5 milligram per day (mg/day) or 10 mg/day once-weekly formulations.
Doses are placed by a patient or caregiver on a patient’s back, upper-outer thigh or upper buttocks. Boston-based Corium reported trial results for Adlarity in a poster (68981) at the Alzheimer’s Association International Conference 2022 in San Diego, according to a news release.
Corium plans for an initial Adlarity launch in early fall 2022, when it will be available for prescription and use. In 2023, the company will begin the national phase of the launch and further build out its commercial team in conjunction with Adlarity becoming covered by Medicare Part D.
“The study results demonstrated that convenient once-weekly Adlarity, which applies Corium’s proprietary Corplex technology, offers significant potential benefit to patients and caregivers because it is equivalent to an oral pill taken daily but offers a lower risk of troublesome GI side effects,” Charles Oh, Corium CMO, said in the release. “This evidence underscores why Adlarity is an important advance in the treatment options for adults with dementia due to Alzheimer’s disease.”
Adlarity delivers seven days of a consistent dose of donepezil through a patient’s skin, maintaining the level of medicine needed for effective treatment, Corium said. Transdermal delivery bypasses the digestive system, resulting in a lower possibility of GI side effects, whereas oral donepezil is absorbed through the digestive system and associated with significant GI side effects and fluctuations in drug concentration, the company noted.
“The doses of the once-weekly donepezil transdermal system were equivalent to oral donepezil on a milligram-per-day basis, and the safety profile of the transdermal system formulation, including the lower overall incidence of GI side effects, supports its use in treating patients with dementia of the Alzheimer’s type,” said Dr. Pierre N. Tariot, lead author of the AAIC 2022 poster and director of the Banner Alzheimer’s Institute in Phoenix, Ariz.
Investigators compared the extent of donepezil exposure from Adlarity against a once-daily oral formulation in 60 healthy adults in the phase 1 trial over treatment periods of five weeks each. Fewer gastrointestinal adverse events occurred with Adlarity than with the oral treatment (14.5% vs. 53.6%, respectively).