OR WAIT null SECS
The company has received a PDUFA action date of March 11, 2022, for Adlarity, a transdermal patch for the treatment of Alzheimer’s disease.
Corium has submitted a new drug application for once-weekly Adlarity (donepezil transdermal system), a patch formulation of donepezil for the treatment of patients with dementia due to mild, moderate, or severe Alzheimer's disease. Corium is seeking approval of two transdermal doses capable of delivering 5 or 10 milligrams of donepezil daily.
This submission is the second one for Adlarity. The company has previously received a complete response letter in July 2020. The current submission contains data from three clinical trials that were conducted in response to that FDA letter.
Adlarity uses the company Corplex technology, which enables transdermal therapeutics that incorporate small molecule drugs to be delivered through the skin. The Adlarity transdermal patch is worn for seven days.
Adlarity contains donepezil, the active ingredient in Pfizer’s/Eisai’s Aricept, which was first launched in 1996, and generics began to be launched in 2011. Corium officials said the transdermal patch aims to avoid the side effects associated with gastrointestinal tract absorption, such as ulcers.
Corium also is developing the Corplex technology for the delivery of drugs to treat patients with other CNS conditions.
If approved, Adlarity would be Corium’s second CNS product approved for the U.S. market in 12 months. In July 2021, Corium commercially launched Azstarys in the United States for the treatment of attention deficient hyperactivity disorder in patients 6 years of age and older, following FDA approval in March 2021.