Boston, MA, March 14, 2022 – Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced today the U.S. Food and Drug Administration (FDA) has approved Corium’s ADLARITY (donepezil transdermal system) as a treatment for patients with mild, moderate, or severe dementia of the Alzheimer’s type. ADLARITY is the first and only once-weekly patch to continuously deliver consistent doses of donepezil through the skin, resulting in a low likelihood of adverse gastrointestinal (GI) side effects associated with oral donepezil. ADLARITY is the first approved prescription drug product using Corium’s proprietary CORPLEX transdermal technology, which has been used for years in consumer products.
Donepezil is the most prescribed medication in a class of Alzheimer's drugs known as acetylcholinesterase inhibitors and is the active ingredient in the oral medication Aricept®. Oral donepezil is absorbed through a patient’s digestive system, a route associated with GI side effects and fluctuations in the concentration of drug in circulation. ADLARITY delivers seven days of a consistent dose of donepezil through a patient’s skin, maintaining the level of medicine needed for effective treatment. The transdermal delivery of donepezil directly into a patient’s skin bypasses the digestive system, resulting in a low possibility of GI side effects and making it easier for patients living with Alzheimer’s disease and their caregivers to administer the treatment reliably.
“The availability of a once-weekly patch formulation of donepezil has the potential to substantially benefit patients, caregivers, and healthcare providers. It offers effective, well-tolerated and stable dosing for seven days for patients who cannot take daily oral donepezil reliably because of impaired memory. It can also offer benefits for those patients who have diminished ability to swallow or have GI side effects associated with ingestion of oral donepezil,” said Pierre N. Tariot, MD, director of the Banner Alzheimer’s Institute in Phoenix, Ariz.
“I am thrilled to hear there is a new medication for people living with Alzheimer’s disease, which uses an existing therapy with an innovative new twist. This easy-to-use skin patch offers bonuses of only needing to be administered once-weekly, which in turn reduces care partners’ responsibilities too. This definitely is a step forward in the right direction,” said Lori La Bey, Care Partner to her mother who lived with dementia for 30 years, 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, according to the World Health Organization. The U.S. Centers for Disease Control and Prevention estimates that in 2020, more than 11 million Americans provided an estimated 15.3 billion hours of unpaid care for patients with Alzheimer’s disease.
Corium, Inc., is a commercial-stage biopharmaceutical company that is leading the development and commercialization of CNS therapies that provide clinicians with important new treatment options for patients, their families, and their caregivers. Corium is commercializing two U.S. FDA approved CNS products in the U.S., ADLARITY and AZSTARYS. Corium has a robust development pipeline focused on addressing unmet needs in the treatment of patients with CNS conditions. In November 2018, all of Corium’s outstanding stock was acquired by an affiliate of Gurnet Point Capital. For further information, please visit http://www.corium.com.
Corium’s President and CEO is Perry J. Sternberg, a biotechnology and pharmaceutical industry leader with more than 25 years of commercial experience across a wide range of therapeutic areas, including ADHD in diverse markets. Prior to joining Corium, Mr. Sternberg served a dual role at Shire Plc (Shire) as the Head of U.S. Commercial for seven therapeutic area business units, as well as the Chief Commercial Officer/Head of the Neuroscience Division, before the acquisition of Shire by Takeda Pharmaceutical Corporation Limited in early 2019.