The FDA has approved a chewable tablet form of extended-release methylphenidate, to be sold as QuilliChew ER, for treatment of attention deficit-hyperactivity disorder (ADHD), .
Methylphenidate, a stimulant drug, was already approved in many different formulations -- including Ritalin -- for treating ADHD. Pfizer previously was OK'd to sell a liquid extended-release version called Quillivant XR.
QuilliChew ER was approved for patients age 6 and older, and will come in strengths of 20, 30, and 40 mg. Tablets will be scored so they can be split easily, providing more flexibility in dosing, Pfizer said. The product is to be taken once daily in the morning. Dosing above 60 mg/day is not recommended, the firm added.
The product's main clinical trial compared it to placebo, showing that the drug was effective in improving attention and behavior in a classroom-type setting.
QuilliChew ER comes with the same long list of cautions and warnings that the FDA has required for other methylphenidate-containing products, including risk of abuse and dependence as well as rare effects such as stroke, heart attack, and death. Increases in blood pressure may be expected, and psychotic or manic symptoms are possible.
The full product label .