The First-Ever Chewable ADHD Medication Approved by the FDA
A new chewable ADHD medication, known commercially as QuilliChew ER, was just approved by the FDA for treating children over the age of six.
December 18, 2015
Pfizer, the same company that produces the liquid ADHD medication Quillivant XR, announced on December 7 that the FDA had approved QuilliChew ER chewable tablets for the treatment of ADHD in children ages six and above.
QuilliChew ER are methylphenidate hydrochloride tablets — the same medication used in Ritalin, Concerta, and Daytrana — that use a proprietary technology that allows for the medication to be slowly released, even after the tablet is broken down as you chew it. The tablet is comprised of tiny methylphenidate spheres, each covered with a coating of varying thickness. QuilliChew is formulated so that 30 percent of the methylphenidate is released immediately. The other 70 percent of the medication is released slowly, as the spheres’ coating dissolves throughout the day.
QuilliChew ER was tested in one double-blind placebo-controlled study, involving 90 children between the ages of six and 12. The study was conducted in a lab/classroom setting, meaning that the children sat in a mock classroom each day while trained teachers and symptom raters tracked their progress. The children were assessed using the Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale — also known as SKAMP — a validated 13-item tool used to assess the severity of ADHD symptoms in classroom environments.
QuilliChew ER demonstrated significant results compared to the placebo at each of the points tested, starting at about 45 minutes after ingestion and lasting approximately eight hours. QuilliChew is cherry flavored and comes in 20, 30, and 40 mg. tablets that — with the exception of the 40 mg. dose — are scored so the dose can be easily adjusted.
In many cases, an eight-hour time frame covers a child’s school day, but parents may feel that their child needs coverage for doing homework and for other after-school activities. Donna Palumbo, Ph.D., the medical affairs director for the ADHD Franchise at Pfizer, says there are no plans yet to make a short-acting QuilliChew formulation to supplement the long-acting formulation. She suggests that parents who want a longer-acting medication look into liquid Quillivant XR, which has shown to last 12 hours. “It’s another option for parents whose children can’t swallow pills,” she says.
As a stimulant medication, QuilliChew ER is a Schedule II controlled substance, but it should be safe if taken at doctor-recommended doses. “We didn’t find any unique side effects for the chewable formulation,” says Palumbo. But, she added, QuilliChew has “similar side effects to other methylphenidate products, including decreased appetite, nausea, and emotional poverty” — or depleted or muted emotions. If your child experiences subdued emotions or a “zombie-like” state — on any stimulant medication — the dose is likely too high, experts say.
QuilliChew ER contains no dairy, gluten, or sugar, but it does have a small amount of red dye in it. Patients who are sensitive to dyes may want to steer clear of the medication. The medication also contains phenylalanine, a component of aspartame.
“We know that some children and adults have PKU,” says Palumbo, referring to phenylketonuria, a condition that causes phenylalanine to build up in the body if not properly treated. “That’s why we’ve included a warning indicating that this part of aspartame is in QuilliChew.” Anecdotal evidence suggests that other patients may be sensitive to aspartame as well, without necessarily having a PKU diagnosis.
Pfizer is currently working with the FDA to develop a preschool-age study to test QuilliChew’s efficacy in children under the age of six. Until then, QuilliChew ER should be available for children six and over starting in early 2016.