Combination of | |
---|---|
Serdexmethylphenidate | Prodrug of dexmethylphenidate |
Dexmethylphenidate | Catecholamine reuptake inhibitor |
Clinical data | |
Trade names | Azstarys |
Other names | KP415 |
AHFS/ Drugs.com | Micromedex Detailed Consumer Information |
License data | |
Routes of administration | By mouth |
ATC code | |
Legal status | |
Legal status |
|
Identifiers | |
KEGG |
Serdexmethylphenidate/dexmethylphenidate, sold under the brand name Azstarys, is a fixed-dose combination medication containing serdexmethylphenidate, a prodrug of dexmethylphenidate, and dexmethylphenidate, a d-threo enantiomer of racemic methylphenidate, which is used to treat attention deficit hyperactivity disorder (ADHD) in people aged six years and older. [1] [2] [3]
Side effects include decreased appetite, nausea, indigestion, weight loss, dizziness, mood swings, increased blood pressure, trouble sleeping, vomiting, stomach pain, anxiety, irritability, and increased heart rate. [4]
It was approved for medical use in the United States in March 2021. [4] [5] [2]
Serdexmethylphenidate/dexmethylphenidate is indicated for the treatment of attention deficit hyperactivity disorder in people six years of age and older. [4]
The US Food and Drug Administration (FDA) approved serdexmethylphenidate/dexmethylphenidate based on evidence from one clinical trial of 150 participants with attention deficit hyperactivity disorder 6 to 12 years of age (Study 1). [4] The four-week trial was conducted at five sites in the United States. [4] The safety and tolerability of serdexmethylphenidate/dexmethylphenidate was examined in an open-label trial of 238 participants with attention deficit hyperactivity disorder 6 to 12 years of age (Study 2). [4] The 12-month trial was conducted at 18 sites in the United States. [4]