Serdexmethylphenidate/dexmethylphenidate
Combination drug
From Wikipedia, the free encyclopedia
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]
| |
| 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 |
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| Identifiers | |
| KEGG | |
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]
Medical uses
Pharmacology
Pharmacokinetics
When administered orally in a 70:30 molar ratio, serdexmethylphenidate/dexmethylphenidate produces a dexmethylphenidate plasma concentration profile with a time to maximum concentration Tmax of approximately 2 hours and an mean terminal elimination half-life of 11.7 hours.[6]
History
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]
