Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved QuilliChew ER chewable tablets. Pfizer now offers two different products for the treatment of ADHD in patients ages 6 years old and above – liquid Quillivant XR® (methylphenidate HCl) CII and new QuilliChew ER chewable tablets.
QuilliChew ER is available in multiple dosage strengths with scored tablet options, which enable healthcare professionals to individualize the dose* to meet the specific treatment needs of patients with ADHD. QuilliChew ER is available in 20 mg scored, 30 mg scored and 40 mg unscored tablet options that are chewable and can be taken with or without food. QuilliChew ER is expected to be available in pharmacies in the first quarter of 2016.
The recommended starting dose is 20 mg given orally once daily in the morning. Dosage may be increased or decreased weekly in increments of 10 mg, 15 mg, or 20 mg per day. Daily dosage above 60 mg is not recommended. Prior to treating pediatric patients and adults with CNS stimulants, including QuilliChew ER, assess for the presence of cardiac disease (i.e. perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam). QuilliChew ER is contraindicated in patients known to be hypersensitive to methylphenidate or other components of QuilliChew ER and hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported. QuilliChew ER is also contraindicated during 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.
“As a physician, it is important to have treatment choices for patients with ADHD and their caregivers. QuilliChew ER extended-release chewable tablets give healthcare providers an additional treatment option to meet their patients’ needs,” said Ann C. Childress, M.D. Dr. Childress is an internationally-recognized expert in the treatment of adolescent psychiatry. She is Board Certified in psychiatry with a sub-specialty in child and adolescent psychiatry, is the president of the Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, and is an adjunct faculty member at the University of Nevada School of Medicine.
QuilliChew ER significantly improved attention and behavior compared to placebo in a clinical trial. The efficacy of QuilliChew ER was evaluated in a double-blind, randomized, placebo-controlled, parallel group laboratory classroom study in 90 children ages 6 to 12 years old with a diagnosis of ADHD based upon criteria in the DSM-IV. The primary and key secondary efficacy parameters were assessed pre- and post-dose, using the SKAMP†-Combined score, measured during the laboratory classroom day at 0.75, 2, 4, 8, 10, 12 and 13 hours. The average of treatment effects across all time points was statistically significantly superior to placebo. The key secondary endpoint demonstrated improvement versus placebo in attention and behavior with an onset at 45 minutes through eight-hour duration (measured at 0.75, 2, 4 and 8 hours post-dosing).
Pfizer is pleased to announce that with new QuilliChew ER, and in partnership with Tris Pharma, the developer of ER chewable tablets, we are expanding our offering of ADHD treatments to include extended-release, chewable tablet options,” said Sam Azoulay, Senior Vice President, Chief Medical Officer, Global Established Pharma, Pfizer.
