Founder of Alzheimer’s Speaks, and Co-founder of Dementia Map.
Corium has deep expertise in transdermal technology and an industry-leading track record
of developing and manufacturing transdermal products. ADLARITY’s approval represents
an important milestone for Corium’s proprietary and proven CORPLEX transdermal
technology. CORPLEX was developed with the goal of optimizing clinical benefits for
patients by delivering continuous, controlled, and sustained release of a drug over a
defined time. Corium is developing other CNS therapies applying its CORPLEX
technology and maintains a robust patent portfolio covering CORPLEX and ADLARITY.
“The FDA approval of ADLARITY brings to market a new and innovative way to deliver
consistently a well-tolerated form of donepezil, the most widely used medicine for patients
with Alzheimer’s disease,” said Perry J. Sternberg, President and CEO of Corium. “The
approval of ADLARITY reinforces the value of Corium’s innovative CORPLEX technology,
our CNS expertise, and our mission to deliver solutions that transform care for the
Alzheimer’s community and others impacted by CNS diseases. We feel truly privileged to
have the opportunity to potentially help millions of people in the U.S. living with
Alzheimer’s disease, their loved ones, and their caregivers with a new option that can
address some of the current challenges in treatment and care.”
The FDA approved the once-weekly use of ADLARITY in 5 mg/day or 10 mg/day
formulations. Patients may be switched from 5 mg/day or 10 mg/day oral donepezil
directly to the once-weekly ADLARITY by their prescriber. ADLARITY is conveniently
placed by a patient or caregiver on a patient’s back, thigh, or buttocks.
ADLARITY Launch and Regulatory Approval Pathway
ADLARITY will be available in early fall 2022. Adlarity was approved pursuant to FDA’s
505(b)(2) regulatory pathway and demonstrated bioequivalence to Aricept. Corium’s drug
application included data from several clinical trials conducted by the company.
ADLARITY is the second CNS product approval, and the second CNS product Corium
will commercialize, in twelve months. In July 2021, Corium launched Azstarys
®
for the
treatment of attention deficit hyperactivity disorder in patients six years of age and older
following FDA approval in March 2021.
About Alzheimer’s Disease
Alzheimer’s disease is a progressive and irreversible brain disorder. It involves changes in
brain tissue including abnormal buildup of proteins as well as loss of neuron function. The
resulting damage leads to the loss of remembering, reasoning, and thinking abilities. The
related behavioral changes include the loss of independence in activities of daily living
and self-care. Dementia ranges in severity from mild, when it is just beginning to affect a
person’s functioning, to moderate, to severe, when the person must depend on others for
the basic activities of day-to-day life. Patients with advanced Alzheimer’s disease may be
unable to chew and swallow easily.
An estimated 6.2 million Americans were living with Alzheimer’s disease in 2021, with a
possible rise to 13.8 million by 2060. Globally, more than 55 million people have
dementia, and Alzheimer's disease may account for 60 to 70 percent of patients,