The US Food and Drug Administration (FDA) has approved a chewable tablet form of extended-release methylphenidate (QuilliChew ER, Pfizer Inc) for attention-deficit/hyperactivity disorder (ADHD) in children aged 6 years and older, the company announced today.
The chewable product will be available in tablet form in strengths of 20, 30, and 40 mg. The tablets will be scored to allow prescribers to individualize the dose to meet the specific needs of individual patients with ADHD. It is to be taken once daily in the morning with or without food. The product is expected to be available in pharmacies in the first quarter of 2016, the company said.
The recommended starting dose is 20 mg daily, with the dosage increased or decreased weekly in increments of 10, 15, or 20 mg per day, the company said. Daily doses higher than 60 mg are not recommended.
QuilliChew ER significantly improved attention and behavior compared with placebo in a blinded, controlled laboratory classroom study involving 90 children aged 6 to 12 years who had a diagnosis of ADHD based on criteria in the DSM-IV, the company said.
“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,” Ann C. Childress, MD, president of the Center for Psychiatry and Behavioral Medicine, Inc, Las Vegas, Nevada, and adjunct faculty member at the University of Nevada School of Medicine, said in the Pfizer news release.
The FDA previously approved Pfizer’s liquid extended-release version of methylphenidate (Quillivant XR) for treatment of ADHD in patients aged 6 years and older.
“CNS stimulants, including Quillivant XR, QuilliChew ER, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence,” the Pfizer release notes. “Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.”