MONMOUTH JUNCTION, N.J., June 08, 2026 (GLOBE NEWSWIRE) -- Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company advancing transformative targeted CNS therapeutics, today announced the availability of DYANAVEL® XR (amphetamine) extended-release oral suspension, CII (2.5 mg/mL) in a new, smaller 60 mL bottle (NDC 24478-102-02). DYANAVEL XR is a once-daily liquid treatment for attention deficit hyperactivity disorder (ADHD) in patients 6 years and older. The new 60 mL bottle size of DYANAVEL XR offers a more convenient size for pharmacy stocking and dispensing and is available through major wholesalers, including Cardinal Health, Cencora, and McKesson. The smaller size is aligned with the approved doses of Dyanavel XR with each 60 mL bottle providing 30 days of the starting dose of 5 mg/day.
“This new bottle size is intended to make DYANAVEL XR easier for pharmacies to stock and, in turn, easier for patients to access,” said Manesh Naidu, Chief Commercial Officer of Tris Pharma. “Pharmacists can now dispense whole bottles to patients for the most commonly prescribed doses while still being able to dispense partial bottles if needed.”
Tris Pharma plans to phase out the larger 464 mL bottle which will be discontinued as the supply switches over to 60 mL bottle size. Storage and handling requirements as well as expiration dating will remain the same for both bottle sizes. No changes have been made to the formulation of DYANAVEL XR. The manufacturer’s price of the medication has not changed with the cost per mL remaining the same in the new 60 mL bottle size.
About Tris Pharma, Inc.
Tris Pharma, Inc. is a privately held, innovation-driven biopharmaceutical commercial-stage company that is applying drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain, and disorders of the central nervous system into advanced, targeted drug delivery. Tris markets a portfolio of best-in-class ADHD products and is developing a robust pipeline of differentiated near-term drug candidates.
For more information, visit www.trispharma.com.
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 maniac 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.
Contact:
Cheryl Patnick
Tris Pharma
732-823-4940
Media Contact:
Madelin Hawtin
LifeSci Communications
MHawtin@lifescicomms.com
