MONMOUTH JUNCTION, N.J.--(BUSINESS WIRE)--Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced additional ex-US regulatory approvals of Quillivant® XR (methylphenidate HCl extended-release oral suspension) and QuilliChew® ER (methylphenidate HCl extended-release chewable tablets) for the treatment of ADHD.
In October, the Saudi Food & Drug Authority (SFDA) approved these products as Quillivant XR Suspension and Quillivant XR Prolonged-Release Tablets for the treatment of ADHD in patients six years and above. Earlier this year, the National Medical Products Administration (NMPA) in China approved Quillivant XR as Methylphenidate Hydrochloride for Sustained-Release Suspension for the treatment of ADHD in patients six years and above; this follows last year’s NMPA approval of QuilliChew ER as Methylphenidate Hydrochloride Extended-Release Chewable Tablets for the treatment of ADHD in patients six years and above. Additionally, Quillivant XR received approval from the Pharmaceutical Division of the Ministry of Health in Israel for the treatment of ADHD earlier this year. Tris Pharma is actively seeking partnerships to facilitate the distribution and availability of Quillivant XR in Israel.
The additional regulatory clearances expand the international availability of these medications beyond Canada, where last year Health Canada authorized the use of these products as Quillivant ER Oral Suspension and Quillivant ER Chewable Tablets for the treatment of ADHD in children ages six to 12. These medications are manufactured in the United States and exported to countries where each has received regulatory approval.
“These additional Quillivant and QuilliChew regulatory approvals are a testament to the growing global recognition that patients could benefit from long-acting ADHD therapies that can be tailored to their individual needs,” said Ketan Mehta, founder and CEO at Tris Pharma. “As the population of people diagnosed with ADHD rises and many countries continue to experience medication shortages, we’re proud to expand the availability of products from our robust ADHD portfolio to potentially support millions of people worldwide living with ADHD.”
Quillivant XR has demonstrated onset of action as soon as 45 minutes through 12 hours post-dose, providing consistent, continuous delivery throughout the day. Quillivant XR oral suspension allows for personalized dosing with ease of titration and the QuilliChew ER chewable tablets have scored tablets, which are ideal for pediatric patients, providing additional flexibility in dose administration with the most dosing options available in an extended-release methylphenidate tablet. Tris developed both formulations using the company’s proprietary LiquiXR® technology.
ADHD diagnosis rates continue to rise globally, likely driven by increased awareness and better diagnostic practices. It is estimated that approximately 129 million children and adolescents aged 5-19 and more than 366 million adults worldwide have ADHD.1-2
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 is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @TrisPharma.
References
1 General Prevalence of ADHD. Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD).
2 Song P, Zha M, Yang Q, et al. The prevalence of adult attention-deficit hyperactivity disorder: A global systematic review and meta-analysis. Journal of Global Health. 2021;11:04009.
IMPORTANT SAFETY INFORMATION
WARNING: ABUSE, MISUSE, AND ADDICTION
Quillivant XR, QuilliChew ER have 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 Quillivant XR, QuilliChew ER, can result in overdose and death. Before prescribing Quillivant XR, 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.
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Quillivant XR and QuilliChew ER are contraindicated:
- in patients known to be hypersensitive to methylphenidate or other components of Quillivant XR and QuilliChew ER. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported.
- during concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also 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 doses. Serious cardiovascular effects with overdose may precipitate sudden cardiac death. Prior to treating patients with Quillivant XR and QuilliChew ER, assess for the presence of cardiac disease. Avoid Quillivant XR and 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 Quillivant XR and 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 Quillivant XR and QuilliChew ER treatment, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing Quillivant XR, and QuilliChew ER.
- Cases of priapism have been reported with methylphenidate use and during a period of withdrawal in both adult and pediatric male patients. Immediate medical attention should be sought in Quillivant XR and QuilliChew ER treated patients who develop abnormally sustained or frequent and painful erections.
- CNS stimulants including Quillivant XR and 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 Quillivant XR and 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 Quillivant XR and 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.
- Quillivant XR and QuilliChew ER treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist.
- Quillivant XR and 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 products have been associated with the onset or exacerbation of motor and verbal tics and worsening of Tourette’s syndrome. Before initiating Quillivant XR and 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.
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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 Quillivant XR and QuilliChew ER in controlled trials.
- Quillivant XR: The most common (≥2% in the Quillivant XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 45 ADHD patients (ages 6-12 years) in Quillivant XR compared to placebo were affect lability (9% Quillivant XR, 2% placebo), excoriation (4%, 0%), initial insomnia (2%, 0%), tic (2%, 0%), decreased appetite (2%, 0%), vomiting (2%, 0%), motion sickness (2%, 0%), eye pain (2%, 0%), and rash (2%, 0%).
- QuilliChew ER: 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. The developmental and health benefits of breastfeeding should be considered along with a mother’s clinical need for Quillivant XR and QuilliChew ER and any potential adverse effects on the breastfed infant from Quillivant XR and QuilliChew ER or from the underlying maternal condition. Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.
- 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/.
- 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
INDICATION
Quillivant XR and QuilliChew ER are central nervous system (CNS) stimulants indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
Please see Full Prescribing Information for Quillivant XR and QuilliChew ER, including Boxed Warning regarding Abuse, Misuse, and Addiction.
