FDA Approves New Orally Disintegrating ADHD Medication Cotempla XR-ODT
The first and only orally disintegrating methylphenidate tablet was approved by the FDA and will become available later this year.
June 20, 2017
Cotempla XR-ODT is the first methylphenidate-based extended-release orally disintegrating tablet for the treatment of ADHD in children between the ages of 6 and 17, according to a company press release. It dissolves in the patient’s mouth, without chewing or drinking water.
The FDA granted approval after a Phase III trial showed significant improvement of ADHD symptoms in a simulated classroom setting. The medication began to show efficacy one hour after it was taken, the company reported, with positive effects lasting up to 12 hours. Side effects were similar to other methylphenidate products, and included no serious adverse effects.
“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,” said Ann Childress, M.D., president of the Center for Psychiatry and Behavioral Medicine in Las Vegas. “It has a clinical profile consistent with commonly prescribed methylphenidate ADHD treatments, which are generally available as capsules that must be swallowed whole.”
“With this approval, Neos will be the only company to have both a branded methylphenidate and a branded amphetamine product available in an extended-release orally disintegrating tablet dosage form,” said Vipin Garg, president and CEO of Neos Therapeutics.
Cotempla XR-ODT has been designated a Schedule II controlled substance, indicating that it has a high potential for abuse. It will be made available in a child-resistant package in the fall of 2017, the company said.
Updated on January 24, 2021