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FDA approves QuilliChew ER for pediatric ADHD
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Pfizer recently announced FDA approval of its QuilliChew ER for treatment of attention-deficit/hyperactivity disorder among children aged 6 years and older, according to a press release.
“Pfizer is pleased to announce that with new QuilliChew ER … we are expanding our offering of ADHD treatments to include extended-release, chewable tablet options,” Solomon Azoulay, MD, chief medical officer of global established pharma for Pfizer, said in the release.
QuilliChew ER (methylphenidate hydrochloride) will be available in 20- and 30-mg scored doses and in 40-mg unscored doses. Scored dosing will allow those administering the drug to adjust the dosage according to the treatment required. The tablets can be taken with or without food.
The FDA approval was based on a double blind, randomized, placebo-controlled laboratory classroom trial of the tablet in 90 children aged 6 to 12 years with diagnosed ADHD, the release said. Children who received the drug displayed significantly improved attention and behavior compared with children who received the placebo.
“As a physician, it is important to have treatment choices for patients with ADHD and their caregivers,” Ann C. Childress, MD, president of the Center for Psychiatry and Behavioral Medicine in Las Vegas, said in the release. “QuilliChew ER extended-release chewable tablets give health care providers an additional treatment option to meet their patients’ need.”
The tablets are expected to be available in early 2016.
Disclosure: Childress reports funding from Pfizer and Shire North American Group.