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.
ANPA Poster # | Title | Authors |
Poster 15
| Serdexmethylphenidate/Dexmethylphenidate (SDX/d-MPH) for Children With Attention-Deficit/Hyperactivity Disorder (ADHD): Reduction in Disorder Severity From a Laboratory Classroom Study | Ann C. Childress, MD; Scott Kollins, PhD; Andrew C. Barrett, PhD; Rene Braeckman, PhD; Sven Guenther, PhD; Travis C. Mickle, PhD; Charles Oh, MD; and Matthew Brams, MD |
Poster 88 | Serdexmethylphenidate/Dexmethylphenidate (SDX/d-MPH) Effects on Sleep in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) | Greg Mattingly, MD; Ann C. Childress, MD; Andrew J. Cutler, MD; Jose Estrada, PhD; and Meg Corliss, PhD |
Poster 87 | Serdexmethylphenidate/Dexmethylphenidate (SDX/d-MPH) Optimized Dose Levels and Effects on Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5) Response Rates in Children With ADHD | Andrew J. Cutler, MD; Meg Corliss, PhD; Andrew C. Barrett, PhD; and Charles Oh, MD |
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.
NAPNAP Poster # | Title | Authors |
Poster 4 | Serdexmethylphenidate/Dexmethylphenidate Effects on Sleep in Children With Attention-Deficit Hyperactivity Disorder | Greg Mattingly, MD; Ann C. Childress, MD; Andrew J. Cutler, MD; Jose Estrada, PhD; and Meg Corliss, PhD |
Poster 3 | A Retrospective Real-World Analysis Demonstrating the Value of Serdexmethylphenidate/ dexmethylphenidate for Patients With Attention-Deficit Hyperactivity Disorder | Steve Faraone, PhD; Mara Lenco, MS; Meg Corliss, PhD; and Charles Oh, MD |
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
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
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
DRUG INTERACTIONS
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
Gartmanpr@gmail.com
202-413-4226
SOURCE Corium, LLC