<img src="https://ml.globenewswire.com/Resource/Download/2ab6667c-5742-4090-afb8-459cd811c92e?size=2" nborder="0" align="left" hspace="5" vspace="5" title="logo.png" alt="Tris Pharma, Inc."/>A new, smaller 30-count bottle of the once-daily chewable methylphenidate offers pharmacists easier stocking and patients a 30-day supply at common dosing levels, available now as families navigate the back-to-school transition QuilliChew ER® offers up to 11 dosing options, providing clinicians flexibility to individualize dosing based on patient needs MONMOUTH JUNCTION, N.J., Sept. 14, 2026 <a href="https://www.globenewswire.com" target="_blank">(GLOBE NEWSWIRE)</a> -- Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company advancing transformative targeted CNS therapeutics, today announced the availability of QuilliChew ER® (methylphenidate HCl) extended-release chewable tablets, CII in 20 mg, 30 mg, and 40 mg strengths in a new, smaller 30-count bottle size. QuilliChew ER is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years of age and older.  The new 30-count bottle size of QuilliChew ER offers a more convenient size for pharmacy stocking and dispensing, and is available through major wholesalers, including Cardinal Health, Cencora, and McKesson. The new size aligns with a 30-day supply at common dosing levels. Additionally, it is available now to support patients and caregivers as they are navigating the back-to-school transition. QuilliChew ER's scored 20 mg and 30 mg tablets can also be divided in half, providing up to 11 total dosing options to support clinicians in titrating to the appropriate dose. The cherry-flavored chewable tablet can be taken without water or food, and may offer a practical solution for some patients who have difficulty swallowing capsules or tablets.  "As families prepare for a new school year, maintaining consistency in ADHD care can be an important part of the transition back to classroom routines," said Manesh Naidu, Chief Commercial Officer of Tris Pharma. "We're proud that Tris' supply has remained unaffected by the sporadic shortages seen across the category, and the addition of 30-count bottles further strengthens that reliability by giving pharmacies a package size that aligns with common monthly dispensing practices. Pharmacies can also still dispense less than a full month's supply when needed, helping ensure patients and caregivers have access to the medications prescribed by their healthcare providers." As part of this transition to the new 30-count bottle size, Tris Pharma will phase out the 100-count bottle size of QuilliChew ER. Storage and handling requirements, as well as expiration dating, remain the same across both bottle sizes. The manufacturer's price of the medication has not changed, with the cost per tablet remaining the same in the new 30-count bottle size.  About QuilliChew ER® (methylphenidate HCl) Extended-Release Chewable Tablets  QuilliChew ER is indicated for the treatment of ADHD in patients 6 years and older. It is available as extended-release chewable tablets in 20 mg, 30 mg, and 40 mg strengths. QuilliChew ER provides symptom control with lasting improvements in ADHD behavioral symptoms of inattention and hyperactivity/impulsivity through the most important parts of the day. These core ADHD symptoms can affect daily functioning across a range of settings, including at school, at work and at home. For more information, visit <a href="https://www.globenewswire.com/Tracker?data=8V0cibho_xgaIEpO8zdskISwOe47reFTFRyN9atsul4YpaD1EilX-KJfvKDoHKO3WTlQMFPd-EUhCTxQHaUu53oPZ-N4gv43Am007PtDPqg=" rel="nofollow" target="_blank" title="QuilliChewERhcp.com">QuilliChewERhcp.com</a>. 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 <a href="https://www.globenewswire.com/Tracker?data=n_s9qwsoOCCvOX_oIwN1Ujkf4nSayiZCcfoxRKktmXFY65kXJz83d_hugsS27kZoQgosdGj0liMr2xbA3Wm_RSEqNZe23QShylqXq9V7aNM=" rel="nofollow" target="_blank" title="">www.trispharma.com</a>.   Indication  QuilliChew ER is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Limitations of Use The use of QuilliChew ER 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 <table style="border-collapse: collapse; width:100%; border-collapse:collapse ;"><tr><td style="width:99.7124%;;text-align: center ; vertical-align: middle; border-right: solid black 1pt ; border-left: solid black 1pt ; border-top: solid black 1pt ; ">WARNING: ABUSE, MISUSE, AND ADDICTION </td></tr><tr><td style="width:99.7124%;;border-right: solid black 1pt ; border-left: solid black 1pt ; border-bottom: solid black 1pt ; ">QUILLICHEW ER 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 QUILLICHEW ER, can result in overdose and death. Before prescribing QUILLICHEW ER, 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. </td></tr></table> <ul type="disc"><li>QuilliChew ER is contraindicated: <ul type="circle"><li style="margin-top:5pt;">In patients known to be hypersensitive to methylphenidate or other components of QuilliChew ER. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported.</li><li style="margin-top:5pt;">During concomitant treatment with monoamine oxidase inhibitors (MAOIs), and within 14 days following discontinuation of treatment with an MAOI because of the risk of hypertensive crisis.</li></ul> </li><li style="margin-top:5pt;">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 dosages. Serious cardiovascular effects with overdose may precipitate sudden cardiac death. Prior to treating patients with QuilliChew ER, assess for the presence of cardiac disease. Avoid QuilliChew ER 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 treatment with QuilliChew ER.</li><li style="margin-top:5pt;">CNS stimulants cause an increase in blood pressure (mean increase approximately 2 - 4 mm Hg) and heart rate (mean increase approximately 3 - 6 bpm). Some individuals may have larger increases. Monitor all patients for hypertension and tachycardia.</li><li style="margin-top:5pt;">Use of CNS stimulants may cause exacerbation of pre-existing psychosis and may induce a 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 QuilliChew ER treatment, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing QuilliChew ER.</li><li style="margin-top:5pt;">Cases of priapism have been reported with methylphenidate use and also during a period of withdrawal in both adult and pediatric male patients. Immediate medical attention should be sought in QuilliChew ER treated patients who develop abnormally sustained or frequent and painful erections.</li><li style="margin-top:5pt;">CNS stimulants including QuilliChew ER used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, 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 QuilliChew ER-treated patients who develop signs or symptoms of peripheral vasculopathy.</li><li style="margin-top:5pt;">CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. QuilliChew ER is not approved for use and is not recommended in pediatric patients below 6 years of age. Closely monitor growth (height and weight) in QuilliChew ER-treated pediatric patients. Pediatric patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.</li><li style="margin-top:5pt;">QuilliChew ER contains phenylalanine, a component of aspartame, and can be harmful to patients with phenylketonuria (PKU). Before prescribing QuilliChew ER in patients with PKU, consider the combined daily amount of phenylalanine from all sources, including QuilliChew ER.</li><li style="margin-top:5pt;">QuilliChew ER-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist.</li><li style="margin-top:5pt;">QuilliChew ER should be prescribed to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Closely monitor QuilliChew ER-treated patients with a history of abnormally increased IOP or open angle glaucoma.</li><li style="margin-top:5pt;">CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics and worsening of Tourette’s syndrome. Before initiating QuilliChew ER, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome. Discontinue treatment if clinically appropriate.</li><li style="margin-top:5pt;">Based on accumulated data from other methylphenidate products, the most common (≥5% and twice the rate of placebo) adverse reactions are:</li></ul> <table style="border-collapse: collapse; width:100%; border-collapse:collapse ;"><tr><td style="max-width:33%; width:33%; min-width:33%;;vertical-align: middle; text-align: left; padding-left: 30.0px; vertical-align: top ; ">- Appetite decreased</td><td style="max-width:33%; width:33%; min-width:33%;;vertical-align: top ; ">- Abdominal pain</td><td style="max-width:34%; width:34%; min-width:34%;;vertical-align: top ; ">- Irritability</td></tr><tr><td style="vertical-align: middle; text-align: left; padding-left: 30.0px; vertical-align: top ; ">- Insomnia</td><td style="vertical-align: top ; ">- Weight decreased</td><td style="vertical-align: top ; ">- Affect lability</td></tr><tr><td style="vertical-align: middle; text-align: left; padding-left: 30.0px; vertical-align: top ; ">- Nausea</td><td style="vertical-align: top ; ">- Anxiety</td><td style="vertical-align: top ; ">- Tachycardia</td></tr><tr><td style="vertical-align: middle; text-align: left; padding-left: 30.0px; vertical-align: top ; ">- Vomiting</td><td style="vertical-align: top ; ">- Dizziness</td><td style="vertical-align: top ; ">- Blood pressure increased</td></tr><tr><td style="vertical-align: middle; text-align: left; padding-left: 30.0px; vertical-align: top ; ">- Dyspepsia</td><td style="vertical-align: top ; "> </td><td style="vertical-align: top ; "> </td></tr></table> <ul type="disc"><li style="margin-top:5pt;">There is limited experience with QuilliChew ER in controlled trials. The most common (≥2% in the QuilliChew ER group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 90 pediatric subjects (ages 6-12 years) in QuilliChew ER compared to placebo were decreased appetite (2.4% QuilliChew ER, 0% placebo), aggression (2.4%, 0%), emotional poverty (2.4%, 0%), nausea (2.4%, 0%), headache (2.4%, 0%), and weight decreased (2.4%, 0%).</li><li style="margin-top:5pt;">There are limited studies on the use of methylphenidate in pregnant women. However, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. To monitor pregnancy outcomes in women exposed to ADHD medications 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 <a href="https://www.globenewswire.com/Tracker?data=KNeoA5h9H9PLBC1NaxMADWh95GDdo6BaQTUnlPvZeRxJoj-H3eqvwORSRPY-7w-cnjJzM56-JMaDitNn2Clxgpa7iwIH8Y3s86zBNo-4njFnkqDDxPk6Sue66WPT5ewzUt9T3ap446L0nD-hGZ_5EmgpBZyH9XxM58BGnkW13t_q_eLO8BGp7I6ZUvd39jzqqLbUl-P0TYRuuPBJTzkukMAEyOY5IEWJ9dK3Kov8ETY2LJu7d7cTWdepFGIypY5-" rel="nofollow" target="_blank" title="">https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/.</a></li><li style="margin-top:5pt;">The developmental and health benefits of breastfeeding should be considered along with a mother’s clinical need for QuilliChew ER and any potential adverse effects on the breastfed infant from QuilliChew ER or from the underlying maternal condition. Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.</li><li style="margin-top:5pt;">To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at (732) 940-0358 or FDA at 1-800-FDA-1088 or <a href="https://www.globenewswire.com/Tracker?data=XYBSNw3I22FO2JjxhFKXjZTrLeiRqQgJ-2cKS9SD0TsdY97Oj2jElT220-DFH2eElbW6wvJYfarKzBjuJRNVXiUKRWqmcmxbS35kuhfyfWsUDugc2QFL6htGCmYUSAIiVQllujeIVHwMo0ZayKyIug==" rel="nofollow" target="_blank" title="">www.fda.gov/medwatch</a></li></ul> Please see <a href="https://www.globenewswire.com/Tracker?data=C0zXZ1PTnAEM-1Hz_-hvi1M-SjEhEFmBocHVke6r0ufj7MXd4mBOxjXTRLirqWNYgipzUXf6PmkLtzon_kiPUWKRGVfeBkk0JiMbIAMb1dD6yzDq2VWwNpVognuLKl_XiVeUP5OBXhy788VUGc68v_v-dmI2ZJelOr1B43SlyZs=" rel="nofollow" target="_blank" title="">Full Prescribing Information</a> for QuilliChew ER, including boxed warning regarding ABUSE, MISUSE, and ADDICTION. QuilliChew ER is a registered trademark of NextWave Pharmaceuticals, Inc. Contact:  Cheryl Patnick  Tris Pharma  732-823-4940  Media Contact:  Madelin Hawtin  LifeSci Communications  <a href="https://www.globenewswire.com/Tracker?data=vK4uyejQTAOdnD_nnD5E2RkpSm3armKRBcQPzdhg-V0DomQ_Z9Jts4hPuAzpXc-_S9hyUuN8vOaQQUKhq43DGe75X7Uah3bg02Ouqy-v5dIG29TXsgQLDiDu4W4NVhKk" rel="nofollow" target="_blank" title="MHawtin@lifescicomms.com">MHawtin@lifescicomms.com</a>   <img alt="" src='https://ml.globenewswire.com/media/NzhjNmM1ZDAtOTU2Zi00M2UwLTg0ZTUtZDc5ZmYxYTJjYjlkLTUwMDE1Njk0MS0yMDI2LTA5LTE0LWVu/tiny/Tris-Pharma-Inc-.png' referrerpolicy='no-referrer-when-downgrade' />

Tris Pharma Introduces New 30-Count Bottle Size for QuilliChew ER® (methylphenidate HCl) Extended-Release Chewable Tablets for Attention Deficit Hyperactivity Disorder (ADHD)

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