The Food and Drug Administration (FDA) recently approved three new treatment choices for pediatric patients 6 years and older with attention-deficit/hyperactivity disorder (ADHD). All are oral extended-release pediatric formulations:
- Adzenys XR-ODT (amphetamine), approved Jan. 27, is the first extended-release orally disintegrating tablet for the treatment of ADHD.
- QuilliChew ER (methylphenidate hydrochloride), approved Dec. 4, 2015, is the first chewable extended-release ADHD tablet. QuilliChew XR can be chewed or swallowed whole.
- Dyanavel XR (amphetamine), approved Oct. 19, 2015, is the first extended-release amphetamine-based oral suspension.
Each of these formulations may be useful for patients who are unable or have difficulty swallowing tablets or capsules. Patient compliance may be enhanced because these extended-release medications are taken once daily.
As part of the approvals for these formulations, the FDA is requiring studies for patients 4-5 years of age.