Chewable ADHD Treatment Approved by FDA

The FDA has approved Pfizer’s chewable formulation of methylphenidate HCl (QuilliChew ER) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years and older.

The agency based its nod on data from a study in which the drug’s efficacy was evaluated in 90 ADHD patients aged 6 to 12 years. Compared with placebo, the use of QuilliChew ER resulted in a statistically significant improvement in attention and behavior, with an onset at 45 minutes through an 8-hour duration.

“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,” said Ann C. Childress, MD, the president of the Center for Psychiatry and Behavioral Medicine in Las Vegas, Nevada, in a press release.

The recommended starting dose of QuilliChew ER is 20 mg orally once daily in the morning, and the dosage may be increased or decreased weekly in increments of 10 mg, 15 mg, or 20 mg per day; dosages above 60 mg per day are not recommended.

QuilliChew ER is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the drug, as well as in those who are currently taking monoamine oxidase inhibitors. Because QuilliChew ER is a Schedule II controlled substance, patients prescribed the drug should be monitored for signs of abuse and dependence during therapy.

Pfizer plans to launch QuilliChew ER in 20-mg, 30-mg, and 40-mg dosage strengths during the first quarter of 2016.