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Important Safety Information Full Prescribing Information
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QuilliChew ER® tablets deliver

Lasting improvements in attention and behavior1

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Primary endpoint: Significant improvement in the average of postdose SKAMP-Combined scores over all time points vs placebo (P<0.001)*1

SKAMP*-Combined Scores With QuilliChew ER Compared With placebo1

Tris ADHD Quillichew combined scores postdose
  • The model adjusted average of all post-dose SKAMP-Combined scores was significantly lower in the QuilliChew ER (methylphenidate HCl) group compared with that in the placebo group1
  • LS mean SKAMP-combined score - QuilliChew ER 12.1; placebo 19.1 (LS mean treatment difference=-7.0 [95% CI: -10.9, -3.1; P<0.001])3
  • A lower SKAMP score indicates an improvement in attention and behavior1
  • The key secondary endpoints demonstrated improvement in attention and behavior measured at 0.75, 2, 4, and 8 hours postdose with QuilliChew ER compared with placebo1,4

Study Details: The study included a 6-week, open-label, dose-optimization treatment period followed by a 1-week, randomized, double-blind, placebo-controlled period. Pediatric subjects (ages 6-12) who met DSM-IV criteria for ADHD, were included. During the open-label period, subjects received QuilliChew ER at a starting dose of 20 mg once daily. At weekly intervals, the dose could be increased in 10–20 mg/day increments to a maximum dose of 60 mg/day or decreased to optimize efficacy and tolerability. The randomized double-blind treatment period included 1 week of double-blind treatment followed by a laboratory classroom evaluation, where efficacy was assessed predose and at 0.75, 2, 4, 8, 10, 12, and 13 hours postdose. The primary efficacy endpoint was the average of all postdose SKAMP-Combined scores. The key secondary endpoints were onset and duration of clinical effect.1,4

Safety data for QuilliChew ER caret

*

The SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham) rating scale, often used in clinical trials, is a validated rating instrument, used by trained raters to specifically measure the observed classroom manifestations of ADHD. The items of the SKAMP are specific for place (the classroom) and time (a typical class period). The scale’s items describe typical behaviors in a classroom setting, and additional items that describe behaviors associated with ADHD in the classroom. The SKAMP method of assessment has been demonstrated to be a sensitive measure of attention and behavior within a lab classroom setting.5

 

ADHD, Attention Deficit Hyperactivity Disorder; CI, confidence interval; LS, least squares.

References: 1. Wigal SB, Childress A, Berry SA, et al. Efficacy and safety of a chewable methylphenidate extended-release tablet in children with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2017;27(8):690-699. 2. Wigal SB, Childress A, Berry SA, et al. Optimization of methylphenidate extended-release chewable tablet dose in children with ADHD: open-label dose optimization in a laboratory classroom study. J Child Adolesc Psychopharmacol. 2018;28(5):314-321. 3. Data on file. Tris Pharma, Inc., Monmouth Junction, NJ. 4. QuilliChew ER [package insert]. Tris Pharma, Inc., Monmouth Junction, NJ. 5. Wigal SB, Gupta S, Guinta D, Swanson JM. Psychopharmacol Bull. 1998;34(1):47-53.

IMPORTANT SAFETY INFORMATION

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WARNING: ABUSE, MISUSE, AND ADDICTION

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.

IMPORTANT SAFETY INFORMATION

INDICATION

QuilliChew ER® (methylphenidate HCI) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

WARNING: ABUSE, MISUSE, AND ADDICTION

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.

  • QuilliChew ER is contraindicated:
    • 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.
    • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Growth should be monitored during treatment with stimulants, including QuilliChew ER. Patients who are not growing or gaining weight as expected may need to have their treatment interrupted.
  • 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.
  • QuilliChew ER-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist.
  • 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. Close monitoring of patients with a history of increased IOP or open angle glaucoma is necessary.
  • 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.
  • 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
    • Blood pressure increased
  • 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%).
  • 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 https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/.
  • 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.
  • To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at (732) 940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information for QuilliChew ER, including Boxed Warning regarding Abuse, Misuse, and Addiction.

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