Corium Receives March 11, 2022 PDUFA Date for New Drug Application for ADLARITY® Patch (donepezil transdermal system) for Treatment of Patients with Alzheimer's Disease
BOSTON, Oct. 12, 2021 /PRNewswire/ -- 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) set a Prescription Drug User Fee (PDUFA) target action date of March 11, 2022 for Corium's new drug application (NDA) for once-weekly ADLARITY (donepezil transdermal system), its lead investigational product and a patch formulation of donepezil for the treatment of patients with dementia due to mild, moderate, or severe Alzheimer's disease. If approved, ADLARITY would be Corium's second CNS product approved for the U.S. market in 12 months.
"Having ADLARITY under consideration by the FDA reflects the significant R&D expertise at Corium. With ADLARITY, Corium has leveraged our innovative Corplex technology to improve the most commonly used first-line treatment for patients with Alzheimer's," said Perry J. Sternberg, President and CEO of Corium. "Our team at Corium is committed to addressing the unmet treatment needs for the Alzheimer's community and others impacted by CNS diseases by developing innovative medicines. We look forward to the FDA's decision early next year."
ADLARITY is a transdermal formulation of donepezil made possible by Corium's proprietary Corplex™ technology. Corplex enables transdermal therapeutics that incorporate small molecule drugs previously thought incapable of delivery through the skin. The ADLARITY transdermal patch is constructed to be worn for seven days with consistent adhesion, a delivery method that avoids the difficulties associated with daily delivery of an oral medication for patients with significant memory problems. Corium also is developing Corplex for the delivery of drugs to treat patients with other CNS conditions, diseases in other therapeutic areas and consumer products beyond those for which it currently is used.
Donepezil, the most prescribed medication in a class of Alzheimer's drugs known as cholinesterase inhibitors, is the active ingredient in Aricept®. The FDA previously approved donepezil as a once-daily tablet and as an orally disintegrating tablet for the treatment of patients with mild, moderate, or severe forms of the disease. With the slow and steady releasing of donepezil, the ADLARITY transdermal system regularly delivers the drug through the skin, a design meant to avoid gastrointestinal tract absorption and associated side effects. Corium is seeking approval of two transdermal ADLARITY doses capable of delivering, respectively, 5 or 10 milligrams of donepezil daily.
Corium is pursuing the approval of ADLARITY via the FDA's 505(b)(2) regulatory pathway and referencing Aricept data. Corium resubmitted the ADLARITY NDA to address questions asked by the FDA in a July 2020 complete response letter. The resubmitted NDA includes data from three clinical trials conducted following receipt of the FDA letter.
About Alzheimer's Disease
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.4 In the United States, an estimated 6.2 million Americans aged 65 and older live with Alzheimer's disease in 2020, but by 2030, the number is projected to increase to 8.2 million, and in 2040, 11.1 million.5,6 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, a contribution valued at $257 billion.7 Alzheimer's disease is the sixth leading cause of death in U.S. adults.8
Other Recent Corium Developments
Corium 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.
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Indication and Important Safety Information for AZSTARYS
AZSTARYS is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older.
WARNING: AZSTARYS is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep AZSTARYS in a safe place to prevent misuse and abuse. Selling or giving away AZSTARYS may harm others and is against the law.
Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Who should not take AZSTARYS?
Do not take AZSTARYS if you or your child are:
Serious problems can occur while taking AZSTARYS. Tell your healthcare provider:
What are possible side effects of AZSTARYS?
The most common side effects of AZSTARYS include:
These are not all the possible side effects of AZSTARYS. Call your doctor for medical advice about side effects.
What is AZSTARYS?
AZSTARYS is a central nervous system (CNS) stimulant prescription medicine for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older. AZSTARYS may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
1 National Institute on Aging. Alzheimer's Disease Fact Sheet. July 8, 2021. Accessed at https://www.nia.nih.gov/health/alzheimers-disease-fact-sheet.
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SOURCE Corium, Inc.