FDA approves chewable pill for pediatric ADHD

December 10, 2015

FDA has approved methylphenidate hydrochloride (QuilliChew ER, Pfizer) extended-release chewable tablets for the treatment of ADHD in children.

FDA has approved methylphenidate hydrochloride (QuilliChew ER, Pfizer) extended-release chewable tablets for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children.

ADHD is one of the most common childhood neurobehavioral disorders, which can also continue through adolescence and adulthood. Patients with ADHD suffer from symptoms such as difficulty paying attention, impulsivity and being overly active. According to data published in 2011 from the CDC, approximately 11% of children aged 4 to 17 years in the United States have been diagnosed with ADHD at any time in their lives.

QuilliChew ER is the first and only long-acting chewable methylphenidate treatment available for ADHD in patients aged 6 years old and older. Methylphenidate is a CNS stimulant that works to improve attention and decrease distractibility by blocking the reuptake of norepinephrine and dopamine into presynaptic neurons. QuilliChew ER is available in multiple dosage strengths with scored tablet options to allow healthcare professionals to individualize the dose to meet specific treatment needs of each patient.

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“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,” says Ann C. Childress, MD, an internationally-recognized expert in the treatment of adolescent psychiatry.

FDA's approval of QuilliChew ER was based on results of a double-blind, randomized, placebo-controlled clinical trial in 90 children ages 6 to 12 years old with a diagnosis of ADHD based upon DSM-IV criteria. Results of the study should that QuilliChew ER significantly improved attention and behavior compared to placebo.

CNS stimulants, such as QuilliChew ER, along with other methylphenidate-containing products, and amphetamines have a high abuse and dependence potential. Healthcare professionals should assess the risk of abuse prior to prescribing, and continue to monitor for signs of abuse and dependence throughout therapy.

The chewable drug will be available in tablet form in strengths of 20, 30, and 40 mg in the first quarter of 2016. 

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