Tris Pharma Expands Support for People Living with ADHD Through New Partnerships with Calm Health and ADHD Central

Initiatives Provide New DYANAVEL® XR Patients With Digital Wellness Resources and Practical Organization Tools Designed to Support ADHD Care Beyond Medication

MONMOUTH JUNCTION, N.J., Aug. 12, 2026 (GLOBE NEWSWIRE) -- Tris Pharma, Inc., a commercial-stage biopharmaceutical company focused on developing innovative therapies for unmet needs, today announced two new partnerships aimed at enhancing the treatment experience for individuals living with Attention-Deficit/Hyperactivity Disorder (ADHD). Through collaborations with Calm Health and ADHD Central, Tris Pharma is extending support beyond prescription treatment by providing patients and their caregivers access to resources focused on mental wellness, organization, and day-to-day success.

As part of the initiative, eligible patients starting treatment with DYANAVEL^® XR will receive three months of complimentary access to Calm Health, a clinical digital mental health platform and self-care app developed by psychologists. Calm Health delivers personalized action plans and evidence-based self-care programs designed to support emotional well-being and mental health. The platform includes ADHD-specific programs that help patients build healthy habits, improve self-management skills, and better navigate the challenges associated with ADHD.

"Effective ADHD management often requires more than medication alone," said Manesh Naidu, Chief Commercial Officer of Tris Pharma. "By partnering with Calm Health and ADHD Central, we hope to provide patients access to tools that may help support both their mental well-being and their daily organization. Our goal is to provide resources to people living with ADHD as they start a new treatment, and these partnerships reflect this commitment to meeting the full range of needs of the ADHD community."

In addition to the Calm Health partnership, Tris Pharma is proud to team up with ADHD Central. This company is dedicated to creating tactile, screen-free, and visual organization tools specifically designed for people with ADHD. Founded by Graham Meckling and Claire Butterfield, ADHD Central develops practical products that help individuals stay organized while reducing digital distractions. Among its offerings are the ON TRACK Cards, a visual task-management system designed to limit digital overwhelm and provide a clutter-free approach to managing daily responsibilities. Through this collaboration, Tris Pharma aims to introduce patients and caregivers to alternative strategies that support focus, productivity, and routine-building in everyday life.

The partnerships underscore Tris Pharma's broader mission to improve outcomes for people living with ADHD, including those who are sub-optimally managed, by expanding access to practical tools and resources that complement treatment and support long-term success. By increasing awareness of trusted mental health resources and practical organizational tools, Tris Pharma hopes to create a more holistic and supportive treatment experience for patients and families.

Indication

DYANAVEL XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.

Limitations of Use

The use of DYANAVEL XR 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.

Important Safety Information

WARNING: ABUSE, MISUSE, AND ADDICTION

DYANAVEL XR has a 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 DYANAVEL XR, can result in overdose and death. Before prescribing DYANAVEL XR, 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 and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

• DYANAVEL XR is contraindicated:
  • In patients known to be hypersensitive to amphetamine, or other components of DYANAVEL XR. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported with other amphetamines.
  • In patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of increased risk of hypertensive crisis.
• Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD doses. Serious cardiovascular effects with overdose may precipitate sudden cardiac death. Prior to treating patients with DYANAVEL XR, assess for the presence of cardiac disease. Avoid DYANAVEL XR use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during DYANAVEL XR treatment.
• CNS stimulants cause increase in blood pressure (mean increase about 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Monitor all patients for potential tachycardia and hypertension.
  
• Use of CNS stimulants may cause exacerbation of pre-existing psychosis and may induce manic or mixed episode in patients with bipolar disorder. In patients without prior history of psychotic illness or mania, CNS stimulants may cause new psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) at the recommended dosage. Prior to initiating DYANAVEL XR treatment, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing DYANAVEL XR.
  
• CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. DYANAVEL XR is not approved for use and is not recommended in pediatric patients below 6 years of age. Closely monitor height and weight in DYANAVEL XR treated pediatric patients treated with CNS stimulants. Treatment may need to be interrupted in children not growing or gaining height or weight as expected.
• CNS stimulants, including DYANAVEL XR, 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. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for DYANAVEL XR-treated patients who develop signs or symptoms of peripheral vasculopathy.
  
• Serotonin syndrome risk is increased when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), MAOIs, and during overdosage situations. If it occurs, discontinue DYANAVEL XR and any concomitant serotonergic agents immediately, and initiate supportive treatment.
  
• CNS stimulants, including amphetamine, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported. Before initiating DYANAVEL XR, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor DYANAVEL XR-treated patients for the emergence or worsening of tics or Tourette’s syndrome and discontinue treatment if clinically appropriate.
  
• Most common adverse reactions observed with amphetamine products: dry mouth, anorexia, weight loss, abdominal pain, nausea, insomnia, restlessness, emotional lability, dizziness, and tachycardia. Based on limited experience with DYANAVEL XR in controlled trials, the adverse reaction profile of DYANAVEL XR appears similar to other amphetamine extended-release products. The most common (≥2% in the DYANAVEL XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 108 patients with ADHD (aged 6 to 12 years) were: epistaxis (DYANAVEL XR 4%, placebo 0%), allergic rhinitis (4%, 0%) and upper abdominal pain (4%, 2%).
  
• DYANAVEL XR use during pregnancy may cause fetal harm. To monitor pregnancy outcomes in women exposed to DYANAVEL XR during pregnancy, healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/.
  
• Because of the potential for serious adverse reactions in a breastfed infant, breastfeeding is not recommended during treatment with DYANAVEL XR.
  
• To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at 1-732-940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  
  

Please see Full Prescribing Information, including Boxed Warning regarding ABUSE, MISUSE, AND ADDICTION

DYANAVEL^® and LiquiXR^® are registered trademarks of Tris Pharma, Inc.

About DYANAVEL^® XR

DYANAVEL^® XR is a long-acting amphetamine-based treatment indicated for the management of ADHD. Designed to provide symptom control throughout the day, DYANAVEL XR offers a treatment option for patients seeking individualized ADHD care.

About Tris Pharma

Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain, addiction and disorders of the central nervous system. Tris markets a portfolio of best-in-class ADHD products and is developing a promising pipeline of differentiated near-term drug candidates.

More information is available at www.trispharma.com and on LinkedIn @TrisPharma.

About Calm Health
Calm Health is an evidence-based, configurable digital mental health solution from the makers of Calm, that helps individuals get the right support and stay engaged to improve health outcomes. Offered through employers, health plans and providers, Calm Health supports commercial, Medicare, Medicaid populations, and more. The platform provides personalized plans informed by an in-app mental health screening and self-reported goals. It connects users to more than 40 clinical programs developed by psychologists to help address stress, anxiety, depression, and trauma related to health conditions, life experiences, and occupational challenges. Users also have access to over 300 hours of Calm’s sleep, mindfulness, and wellness content. Calm Health is HIPAA- and HITRUST-compliant and supports 39 million eligible members worldwide, with localized support in ten languages.

To learn more, visit health.calm.com.

About ADHD Central

ADHD Central is a small business creating screen-free, analog productivity tools designed specifically for ADHD brains. Founded by Graham Meckling and Claire Butterfield, the company builds tactile, paper-based products, including its flagship ON TRACK Cards, a pocket-sized daily planning system, that help people write things down, reduce digital overwhelm, and build habits that stick. ADHD Central's growing product line spans task prioritization, habit tracking, and brain-dump tools, all grounded in the idea that writing by hand strengthens working memory and helps ADHD brains organize, focus, and follow through.

To learn more, visit adhdcentral.com.

Company Contact
Cheryl Patnick
Tris Pharma, Inc.
cpatnick@trispharma.com

Media Contact
Madelin Hawtin
LifeSci Communications
MHawtin@lifescicomms.com