FDA: Chewable Tablet Approved For ADHD

Just recently, the U.S. Food and Drug Administration has approved the chewable form of extended-release methylphenidate, a prescription drug used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

In their website, pharmaceutical company Pfizer said that QuilliChew ER chewable tablets have been approved and is the second in their line of drugs used to treat ADHD in patients aged 6 and above.

Previously, the company received approval for Quillivant XR, a liquid form of the extended-release drug.

According to MedPage Today, methylphenidate is a stimulant drug. Some of its formulations have already been approved for use, one of which is Ritalin.

QuilliChew ER is reported to come in different strengths, either 20, 30 or 40 milligram tablets. The 20mg and 30mg tablets will be scored so that they can be easily split, making it easy for patients to adjust to their dosage intake based on their individual needs.

“As a physician, it is important to have treatment choices for patients with ADHD and their caregivers,” Ann C. Childress, M.D., an internationally-recognized expert in the treatment of adolescent psychiatry, said. “QuilliChew ER extended-release chewable tablets give healthcare providers an additional treatment option to meet their patients’ needs.”

In a clinical trial, QuilliChew ER was able to significantly improve attention and behavior compared to a placebo.

In a classroom study involving 90 children ages 6 to 12 years old who were diagnosed with ADHD based on the criteria found in the DSM-IV, it was found that QuilliChew ER was able to help the kids have significantly better attention and behavior versus placebo.

“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 and chief medical officer of the internationally-established pharmaceutical corporation, Pfizer.

Pfizer said that the recommended dosage is 20mg, which should be taken orally only once a day, in the morning. Dosage can be increased or decreased weekly in 10mg , 15mg or 20mg increments. However, a dosage higher than 60mg is not recommended. Pfizer added that the tablets can be taken with or without food.

The full product label can be seen here.

The pharmaceutical company reminded that, prior to giving doses of the the chewable drug or any other drug that includes CNS stimulants, it is vital that the patients be checked for any presence of cardiac disease.

QuilliChew ER is expected to be available in pharmacies within the first three months of 2016.