Collegium To Present Pediatric And Real-World Research Across ADHD Portfolio At AACAP And NEI Fall Congresses

(MENAFN- GlobeNewsWire - Nasdaq) Seven presentations include pediatric Phase 4 studies of AZSTARYS® (Serdexmethylphenidate/dexmethylphenidate) CII and real-world research of JORNAY PM® (Delayed-Release/Extended-Release Methylphenidate) CII in adults and impact on caregivers

STOUGHTON, Mass., Oct. 21, 2026 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading biopharmaceutical company focused on improving the lives of people living with serious and often misunderstood conditions, today announced that seven abstracts from its attention-deficit/hyperactivity disorder (ADHD) portfolio have been accepted for presentation at two scientific congresses this fall. The presentations span pediatric clinical studies and research examining daily functioning among adults and caregivers, reflecting Collegium's commitment to building a broader understanding of ADHD across ages and real-life settings.

The data will be presented at the American Academy of Child and Adolescent Psychiatry (AACAP) 2026 Annual Meeting, taking place October 26–31 in Atlanta, and the Neuroscience Education Institute (NEI) Fall Congress, taking place November 5–8 in Colorado Springs.

The abstracts include Phase 4 studies of AZSTARYS® (Serdexmethylphenidate/dexmethylphenidate) CII in pediatric populations, as well as retrospective analyses of JORNAY PM® (Delayed-Release/Extended-Release Methylphenidate) CII from routine clinical practice in adults, and survey research with caregivers of children and adolescents. The real-world analyses are observational, and the investigators describe their findings as hypothesis-generating.

An estimated 15.5 million adults and 7 million children and adolescents in the United States have ADHD.^1,2Published research has associated ADHD symptom severity with greater family burden, reduced family functioning, and lower quality of life among parents.³Subsequent work indicates that when ADHD symptoms are inadequately controlled, routine aspects of the morning can create one of the most stressful parts of the day for both parents and children.⁴

"People living with ADHD, and the families who support them, need care they can count on throughout the day, so they can focus on school, work, and time with the people around them,” said Thomas Smith, M.D., Executive Vice President and Chief Medical Officer, Collegium Pharmaceutical, Inc.“The clinical studies and real-world research we're presenting this fall help deepen the understanding of those daily needs and advance how ADHD is managed.”

Presentations

American Academy of Child and Adolescent Psychiatry (AACAP) 2026 Annual Meeting

October 26–31, 2026 | Atlanta, Georgia

• A Phase 4 Safety, Tolerability, and Efficacy Study of Serdexmethylphenidate/dexmethylphenidate in Children with Attention-Deficit/Hyperactivity Disorder Childress AC, Newcorn JH, Tashjian R, Corliss M. Friday, October 30
  

Neuroscience Education Institute (NEI) Fall Congress

November 5–8, 2026 | Colorado Springs, Colorado

• A Phase 4, Randomized, Double-blind Study of Serdexmethylphenidate/dexmethylphenidate in Children with Attention-Deficit/Hyperactivity Disorder Childress AC, Newcorn JH, Lewis L, Adusumilli S, Tashjian R, Corliss M.
  Friday, November 7
• A Phase 4 Safety, Tolerability, and Efficacy Study of Serdexmethylphenidate/dexmethylphenidate in Children Aged 4–5 Years with Attention-Deficit/Hyperactivity Disorder Childress AC, Newcorn JH, Lewis L, Tashjian R, Corliss M.
  Friday, November 7
• Modeling Clinical Response Patterns of AZSTARYS (SDX/d-MPH) and Other ADHD Pharmacotherapies Using Real-World Clinical Data Young J, Powell R, Powell A, Welling L, Saal J, Friedman Fechter E, Friedman H, Nash M.
  Friday, November 7
• The Association Between Delayed-Release/Extended-Release Methylphenidate Starting Dose and Treatment Persistence in Adults with ADHD Young J, Powell R, Powell A, Welling L, Friedman Fechter E, Friedman H, Saal J, Nash M.
  Friday, November 7
• Morning Functioning During Evening-Dosed Delayed-Release/Extended-Release Methylphenidate in Adults With ADHD: A Retrospective Real-World Analysis Young J, Powell R, Powell A, Welling L, Friedman Fechter E, Friedman H, Saal J, Nash M.
  Friday, November 7
• Morning Functioning and Caregiver Strain Across ADHD Medication Regimens: A Real-World Survey Study Young J, Powell R, Powell A, Welling L, Friedman Fechter E, Friedman H, Saal J, Nash M.
  Friday, November 7

About Collegium Pharmaceutical, Inc.

Collegium Pharmaceutical is a dynamic biopharmaceutical company delivering medicines with formulation and delivery innovation for people living with complex central nervous system (CNS) and pain conditions. Collegium has spent more than a decade proving that responsible stewardship and bold, science-backed approaches can redefine what treatment looks like in categories too often shaped by complexity and misconceptions.

With a portfolio of differentiated ADHD medications, anchored by JORNAY PM® (methylphenidate HCl) CII and AZSTARYS® (serdexmethylphenidate and dexmethylphenidate) CII, and an established leadership position in responsible pain management, Collegium leads with the scientific rigor and commercial expertise to deliver treatment options around how people live their lives.

For more information, please visit collegiumpharma.com or find us on LinkedIn.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: ABUSE, MISUSE, AND ADDICTION

JORNAY PM and AZSTARYS have high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including JORNAY PM and AZSTARYS, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing JORNAY PM or AZSTARYS, assess each patient's risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient's risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse and addiction.

CONTRAINDICATIONS

Known hypersensitivity to methylphenidate, serdexmethylphenidate, or other components of JORNAY PM or AZSTARYS. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate products.

Concomitant treatment with monoamine oxidase (MAO) inhibitors, or within 14 days following discontinuation of a MAOI, because of the risk of hypertensive crisis.

WARNINGS AND PRECAUTIONS

Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease.

Increased Blood Pressure and Heart Rate.

Psychiatric Adverse Reactions: Prior to initiating JORNAY PM or AZSTARYS, screen patients for risk factors for developing a manic episode.

Priapism: If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention.

Peripheral Vasculopathy, including Raynaud's Phenomenon: Observe patients for digital changes during treatment.

Long-Term Suppression of Growth in Pediatric Patients: Closely monitor growth (height and weight) in pediatric patients. Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted.

Acute Angle Closure Glaucoma and Increased Intraocular Pressure (IOP): Patients considered at risk for acute angle closure glaucoma and IOP should be evaluated by an ophthalmologist.

Motor and Verbal Tics, and Worsening of Tourette's Syndrome.

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.

Additional adverse reactions (≥5% and twice the rate of placebo) in JORNAY PM-treated pediatric patients 6 to 12 years are headache, psychomotor hyperactivity, and mood swings.

DRUG INTERACTIONS

Adjust dosage of antihypertensive drug as needed. Monitor blood pressure.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or

INDICATION
JORNAY PM (methylphenidate HCl) extended-release capsules and AZSTARYS (serdexmethylphenidate and dexmethylphenidate) capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older.

Limitations of Use: It is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage.

Please click here for Full Prescribing Information for JORNAY PM and AZSTARYS, including Boxed Warning.

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References

Staley BS, Robinson LR, Claussen AH, et al. Attention-Deficit/Hyperactivity Disorder Diagnosis, Treatment, and Telehealth Use in Adults - National Center for Health Statistics Rapid Surveys System, United States, October–November 2023. MMWR Morb Mortal Wkly Rep. 2024;73(40):890-895.

Danielson ML, Claussen AH, Bitsko RH, et al. ADHD Prevalence Among U.S. Children and Adolescents in 2022: Diagnosis, Severity, Co-Occurring Disorders, and Treatment. J Clin Child Adolesc Psychol. 2024;53(3):343-360. doi:10.1080/15374416.2024.2335625

Peñuelas-Calvo I, Palomar-Ciria N, Porras-Segovia A, et al. Impact of ADHD symptoms on family functioning, family burden and parents' quality of life in a hospital area in Spain. Eur J Psychiatry. 2021;35(3):166-172.

Sallee FR. Early Morning Functioning in Stimulant-Treated Children and Adolescents with Attention-Deficit/Hyperactivity Disorder, and its Impact on Caregivers. J Child Adolesc Psychopharmacol. 2015 Sep;25(7):558-65. doi: 10.1089/cap.2014.0160. Epub 2015 Jul 7. PMID: 26151738; PMCID: PMC4576958.

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