Methylphenidate Extended-Release Orally Disintegrating Tablet
The FDA has approved Cotempla XR-ODT, an extended-release, orally disintegrating methylphenidate tablet, for the treatment of ADHD in children ages 6 to 17 years old. Cotempla XR-ODT is the first orally disintegrating formulation of methylphenidate available, and provides an alternative option for patients who have difficulty swallowing pills. In clinical trials, the onset and duration of action of Cotempla XR-ODT was tested in a laboratory classroom setting; efficacy was evident at one hour postdose and lasted for 12 hours, allowing for once daily dosing. There were no serious adverse events reported. Cotempla XR-ODT is expected to be available in the fall of 2017.
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Amphetamine Mixed Salts Once-Daily Capsule
The FDA has approved Mydayis, a mixed salts amphetamine formulation, for the treatment of ADHD in patients ages 13 years and older. Mydayis uses three different types of drug-releasing beads, allowing for both early onset of action and sustained efficacy throughout the day with a single morning dose. In clinical trials, Mydayis demonstrated an onset of action at 2–4 hours and a duration of action of up to 16 hours. Adverse events were similar to those reported with other amphetamine products. Mydayis is expected to be available in the fall of 2017.
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