Corium to Report Positive Data on ADHD Medication AZSTARYS® (serdexmethylphenidate and dexmethylphenidate) at 2023 American Neuropsychiatric Association Annual Meeting and at 2023 National Association of Pediatric Nurse Practitioners Conference

AZSTARYS data includes durable ADHD symptom improvement, dose optimization effects, improved sleep impact, and real-world claims analysis

AZSTARYS is the first and only treatment for ADHD containing an immediate release component and the prodrug serdexmethylphenidate, together providing rapid and extended duration of symptom improvement

BOSTON, March 13, 2023 /PRNewswire/ -- Corium, LLC, a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announces the upcoming presentation of positive data about its first-in-class attention-deficit hyperactivity disorder (ADHD) medicine AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) at two national medical association meetings this month.

Azstarys is the first and only once-daily treatment for ADHD symptoms containing SDX, the prodrug of d-MPH. SDX is designed specifically to be pharmacologically inactive until reaching a patient's lower gastrointestinal tract, where, by design, the prodrug gradually converts to d-MPH throughout the day. This formulation provides control of ADHD symptoms both rapidly with the immediate-release d-MPH and for an extended duration with SDX. Azstarys is indicated for patients aged six years and older with ADHD.

The presentations this month will report the effect of AZSTARYS on reducing ADHD severity in children in a pivotal classroom study, the effects of optimized AZSTARYS pediatric dosing, and the medicine's sleep effects in children. A real-world claims database analysis will report on the value of AZSTARYS therapy for adult and pediatric patients as measured by their need to add a short-acting ADHD drug to their ongoing AZSTARYS regimen.

"The positive outcomes in these analyses reinforce the benefits AZSTARYS offers to children six years and older and adults with ADHD, including rapid on-set of action, durable day-long efficacy, and proven safety," said Charles Oh, M.D., Chief Medical Officer of Corium. "Our participation at the 2023 annual meetings of the American Neuropsychiatric Association and the National Association of Pediatric Nurse Practitioners also embody Corium's ongoing commitment to research and share scientific knowledge as a leader in the CNS therapeutic space."

Corium's three posters at the American Neuropsychiatric Association (ANPA) 2023 meeting will be presented on Wednesday, March 15, from 5:30 to 7:00 p.m. EDT (Poster 15), and Friday, March 17, from 6:00 to 7:30 p.m. (Posters 87 and 88) in Staffordshire Room of the Westin at Copley Place in Boston, MA.   

Corium's two posters at the National Association of Pediatric Nurse Practitioner's 44th National Conference on Pediatric Health Care (NAPNAP) meeting will be presented on Wednesday, March 15 from 12:30 to 1:30 p.m. at the Rosen Shingle Creek in Orlando, FL.

About ADHD
ADHD is a common neurodevelopment disorder marked by an ongoing pattern of inability to pay attention or hyperactivity with impulsive behaviors, or both, which interferes with functioning or development. ADHD usually is diagnosed during childhood but often continues into adulthood. Children with ADHD may have trouble paying attention, controlling impulsive behaviors (may act without thinking about what the result will be), or be overly active. In the United States, an estimated 6.1 million children have received an ADHD diagnosis, including 2.4 million aged 6 to 11 years.

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

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.

About Corium
Corium, LLC, is a commercial-stage biopharmaceutical company that is leading the development and commercialization of CNS therapies that provide physicians with innovative treatment options for patients, their families, and their caregivers. Corium is commercializing two FDA approved products, ADLARITY and AZSTARYS. For further information, please visit https://www.corium.com/.

Contact:
Corium, LLC
[email protected] 
202-413-4226

SOURCE Corium, LLC