The US FDA has approved a new, once-daily oral stimulant medication for the treatment of attention deficit hyperactivity disorder (ADHD) in people aged 6 years and older.
Azstarys (KemPharm, Inc) combines serdexmethylphenidate (SDX) + dexmethylphenidate (d-MPH), coformulated with immediate-release d-MPH.
Dosage: Azstarys will be available in three once-daily dosage strengths of SDX/d-MPH: 26.1 / 5.2 mg, 39.2 / 7.8 mg, and 52.3 / 10.4 mg.
Adverse effects: headache, upper abdominal pain, insomnia and pharyngitis.
Pharmacology: Following absorption in the gastrointestinal tract, SDX is converted to d-MPH, which is gradually released throughout the day, providing symptom control both rapidly with the d-MPH and for an extended duration with SDX.
Study: The study included 150 children aged 6 to 12 years with ADHD. Compared with placebo, treatment with Azstarys led to significant improvement in ADHD symptoms, as measured by the primary endpoint, the change from baseline in Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale – Combined (SKAMP-C) scores averaged over 13 hours.
The FDA has recommended a schedule II controlled substance classification for Azstarys.
Source: FDA