FDA Clears New Methylphenidate Formulation for ADHD

Megan Brooks

June 20, 2017

The US Food and Drug Administration (FDA) has approved a new formulation of methylphenidate for children with attention-deficit/hyperactivity disorder (ADHD).

Cotempla XR-ODT (Neos Therapeutics Inc) is the first and only methylphenidate extended-release orally disintegrating tablet for the treatment of ADHD in patients aged 6 to 17 years, the company said in a news release.

The recommended starting dose for pediatric patients aged 6 to 17 years is 17.3 mg given orally once daily in the morning. The dose could be titrated on a weekly basis from 17.3 mg, to 25.9 mg, to 34.6 mg, up to 51.8 mg until an optimal dose or the maximum dose of 51.8 mg/day is reached.

The approval of Cotempla XR-ODT was based on results of a phase 3 study in children in a laboratory classroom setting.

In the study, once-daily treatment with Cotempla XR-ODT led to a statistically significant improvement in ADHD symptom control compared to placebo across the classroom day (placebo-subtracted difference of -11; 95% confidence interval, -13.9 to -8.2).

Onset of effect was evident 1 hour after administration and lasted 12 hours. No serious adverse events were reported during the study, and the adverse event profile was consistent with the established safety profile for other extended-release methylphenidate products, the company said.

"Cotempla XR-ODT offers a new methylphenidate option in ADHD management because it dissolves in the mouth with no need for chewing or drinking water. It has a clinical profile consistent with commonly prescribed methylphenidate ADHD treatments, which are generally available as capsules that must be swallowed whole," Ann Childress, MD, president of the Center for Psychiatry and Behavioral Medicine, Las Vegas, Nevada, said in the release.

"Cotempla XR-ODT will offer physicians and their patients a differentiated treatment option that combines the convenience of once-daily dosing with an orally disintegrating methylphenidate dosage form," she added.

The company said Cotempla XR-ODT will be commercially available in a portable, child-resistant blister pack in the fall of 2017.

Full prescribing information and medication guide are available online.


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