One biopharmaceutical company has finished clinical trials for its new transdermal patch for the treatment of Alzheimer’s disease, and the results show similarities to the widely used oral version of the drug.
Adlarity, the new treatment, is a form of donepezil and is marketed as an alternative to the oral medication. The skin patch was approved by the U.S. Food and Drug Administration earlier this year, while the pill form has been in use since the 1990s.
The skin patch, according to a statement from Corium, the drug’s Michigan-based manufacturer, showed an equal daily exposure of donepezil with weekly application as a standard daily pill. This implies patients can get the same level of treatment with the weekly patch application as they could taking the oral medication daily.
…patients can get the same level of treatment with the weekly patch application as they could taking the oral medication daily.
Corium also touts the gastrointestinal benefits of not needing to take the daily pill and claims a “favorable overall gastrointestinal side effect profile” with the patch. Dr. Pierre N. Tariot, MD, director of the Banner Alzheimer’s Institute, said the results show the patch could be a safe alternative to oral medication.
“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, support its use in treating patients with dementia of the Alzheimer’s type,” Tariot said in a statement.
Marketed as a first-of-its-kind treatment, Adlarity uses proprietary transdermal technology known as Corplex. The small-molecule technology is in use in several commercially available products, notably Crest Whitestrips.
Corium is targeting early fall availability for Adlarity, which was tested with and will be available in 5 mg and 10 mg dosages. The drug is approved to treat “mild, moderate or severe dementia of the Alzheimer’s type,” making it potentially available to a wide range of patients.
The FDA did not approve Adlarity after Corium’s first application in 2020, but received approval earlier this year after resubmitting the application with updated information.
Two other Alzheimer’s meds may be on the way
- Quince Therapeutics, formerly known as Cortexyme, is testing its COR588 oral medication, a treatment designed to block the growth of the toxic protein gingipains, which is a protein associated with Alzheimer’s as well as gum disease. COR588 is a newer version of a previously developed product, COR388, which did not meet expectations in testing and has been put on hold by the FDA. COR588, in contrast, showed signs of being safe and able to penetrate the spinal cord, according to Alzheimer’s News Today.
- Alzheon’s ALZ-801 treatment showed promising results in an interim analysis of phase 2 testing, lowering p-tau 181 levels in patients. P-tau 181 is a marker associated with Alzheimer’s. The oral agent has now moved on to phase 3 testing, according to Alzheimer’s News Today.