FDA Approves Mydayis (mixed salts of a single-entity amphetamine) for ADHD in Patients 13 and Older

Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mechanism of action in ADHD is not known.

Mydayis is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older. Limitations of Use: Pediatric patients 12 years and younger experienced higher plasma exposure than patients 13 years and older at the same dose and experienced higher rates of adverse reactions, mainly insomnia and decreased appetite.

Mydayis should be administered once daily upon awakening. The recommended starting dose for adults (18 to 55 years) is 12.5 mg once daily, with titration in increments of 12.5 mg no sooner than weekly, up to a maximum of 50 mg daily. For pediatric patients (13 to 17 years), the starting dose is 12.5 mg once daily, with titration up to a maximum of 25 mg daily. In adult patients with severe renal impairment (GFR 15 to <30 mL/min/1.73 m2), the maximum dose is 25 mg daily; use in ESRD is not recommended. In pediatric patients with severe renal impairment, the maximum dose is 12.5 mg. Mydayis may be taken with or without food, but patients should be consistent. Capsules may be swallowed whole or opened and sprinkled over applesauce. Do not substitute for other amphetamine products on a milligram-per-milligram basis.

Efficacy of Mydayis in ADHD was established in three short-term trials in adults (18 to 55 years, Studies 1, 2, and 3) and two short-term trials in pediatric patients (13 to 17 years, Studies 4 and 5). Specific efficacy results are not reported in the label.

Prior to treatment, assess for presence of cardiac disease (careful history, family history of sudden death or ventricular arrhythmia, and physical exam). Evaluate for motor or verbal tics or Tourette's syndrome. Because effects may last up to 16 hours, administer upon awakening to avoid insomnia. Do not administer later in the day if a dose is missed. Acidifying agents (e.g., ascorbic acid) decrease amphetamine blood levels; alkalinizing agents (e.g., sodium bicarbonate) increase levels. Adjust dosage accordingly.

Mydayis offers a once-daily formulation with a long duration of effect (up to 16 hours) for ADHD patients 13 years and older. It is not indicated for younger children due to higher exposure and adverse reactions. Dosing is limited in renal impairment.