Corium Receives FDA Approval of ADLARITY® (donepezil transdermal system) for Treatment of Patients with Alzheimer's Disease

First and only once-weekly patch for convenient, well-tolerated delivery of most used drug for treatment of Alzheimer's-related dementia

First approved prescription drug using Corium's proprietary CORPLEX™ technology, used for years in consumer products

Second CNS product approval for Corium in 12 months

BOSTON, March 14, 2022 /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) 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.

About Corium
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.

About Gurnet Point Capital
Gurnet Point Capital is a unique healthcare investment platform within the B-Flexion group and led by a team with deep expertise in an industry for which they share a passion, both as investors and senior executives. GPC invests long-term capital and supports entrepreneurs in building a new generation of companies that deliver outsized returns through active ownership. Based in Cambridge, MA, its remit encompasses life sciences and health care focused businesses, with a particular emphasis on businesses that have high growth potential in the product development and commercialization stages of their evolution. With its strategy of driving best in class operational transformation for these businesses, to create social impact while generating significant economic value, GPC is able to deliver differentiated results for its investors and partners. For more, go to http://www.gurnetpointcapital.com.

INDICATION
ADLARITY is indicated for the treatment of mild, moderate, and severe dementia of the Alzheimer's type.

IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS
ADLARITY is contraindicated in patients with known hypersensitivity to donepezil or to piperidine derivatives or with a history of allergic contact dermatitis with use of ADLARITY.

WARNINGS AND PRECAUTIONS

• Application site skin reactions: ADLARITY may cause skin application-site reactions. These reactions are not necessarily indicative of sensitization; however, allergic contact dermatitis may occur and should be suspected if application-site reactions spread beyond the size of the transdermal system, there is evidence of a more intense local reaction, and symptoms do not significantly improve within 48 hours of transdermal system removal.
• Anesthesia: ADLARITY is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia.
• Cardiovascular conditions: ADLARITY may have vagotonic effects on the sinoatrial and atrioventricular nodes. These effects may manifest as bradycardia or heart block in patients both with and without known underlying cardiac conduction abnormalities. Syncopal episodes have been reported in association with the use of donepezil.
• Nausea and vomiting: ADLARITY may cause diarrhea, nausea, and vomiting. Although in most cases these effects have been transient, some cases lasted 1 to 3 weeks. Patients should be monitored closely during initiation and titration of ADLARITY.
• Peptic ulcer disease and gastrointestinal bleeding: ADLARITY may increase gastric acid secretion. Patients should be monitored closely for active or occult gastrointestinal bleeding, especially those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs).
• Genitourinary conditions: Although not observed in clinical trials of ADLARITY, bladder outflow obstruction may occur.
• Seizures: ADLARITY is believed to have some potential to cause generalized convulsions; however, seizure activity may also be a manifestation of Alzheimer's disease.
• Pulmonary conditions: ADLARITY should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.

ADVERSE REACTIONS
The most common side effects of ADLARITY (>3%) were headache (15%), application-site pruritus (9%), muscle spasms (9%), insomnia (7%), abdominal pain (6%), application-site dermatitis (6%), constipation (6%), diarrhea (4%), application site pain (4%), dizziness (4%), abnormal dreams (4%) and skin laceration (4%).

DRUG INTERACTIONS
Cholinesterase inhibitors, including donepezil, have the potential to interfere with the activity of anticholinergic medications. A synergistic effect may be expected when cholinesterase inhibitors are given concurrently with succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists such as bethanechol.

For additional safety information, click here for the Prescribing Information and Patient Information.

Indication and Important Safety Information for AZSTARYS (serdexmethylphenidate and dexmethylphenidate)

Indication
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.

IMPORTANT SAFETY INFORMATION

WARNING: abuse and dependence

• CNS stimulants, including AZSTARYS, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy

Contraindications

• Known hypersensitivity to serdexmethylphenidate, methylphenidate, or other product components. Bronchospasm, rash, and pruritus have occurred with AZSTARYS. Hypersensitivity reactions such as angioedema and anaphylactic reactions have occurred with other methylphenidate products.
• Concomitant treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within the preceding 14 days, because of the risk of hypertensive crisis.

Warnings and Precautions

• Sudden death has been reported in association with CNS stimulant treatment at recommended doses in pediatric patients with structural cardiac abnormalities or other serious heart problems. In adults, sudden death, stroke, and myocardial infarction have been reported at recommended doses. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmias, coronary artery disease, or other serious heart problems.
• CNS stimulants cause an increase in blood pressure and heart rate. Monitor all patients for hypertension and tachycardia.
• Exacerbation of Pre-existing Psychosis: May exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder: May induce a mixed/manic episode in patients with bipolar disorder. Prior to initiating treatment, screen for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms, or a family history of suicide, bipolar disorder, or depression). New Psychotic or Manic Symptoms: At recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a history of psychotic illness or mania. Discontinue if symptoms occur.
• Cases of painful and prolonged penile erections and priapism have been reported with methylphenidate products. Immediate medical attention should be sought if signs or symptoms of prolonged penile erections or priapism are observed.
• CNS stimulants, including AZSTARYS, are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Carefully observe patients during treatment for digital changes. Further evaluation may be required, including referral.
• CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Monitor height and weight at appropriate intervals in pediatric patients. Treatment may need to be interrupted in children not growing or gaining weight as expected.

Adverse Reactions

• Based on accumulated data from other methylphenidate products, the most common (>5% and twice the rate of placebo) adverse reactions are appetite decreased, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect lability, tachycardia, and blood pressure increased.

Drug Interactions

• Adjust dosage of antihypertensive drug as needed. Monitor blood pressure.
• Avoid use of AZSTARYS on the day of surgery if halogenated anesthetics will be used.

For additional safety information, click here for Prescribing Information and Medication Guide, including BOXED WARNING.

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.

Contact:
Corium, Inc.
Gartman PR
[email protected]
202-413-4226

SOURCE Corium, Inc.