Serdexmethylphenidate/dexmethylphenidate
Combination of
SerdexmethylphenidateProdrug of dexmethylphenidate
DexmethylphenidateCatecholamine reuptake inhibitor
Clinical data
Trade namesAzstarys
Other namesKP415
AHFS/Drugs.comMicromedex 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]

Medical uses

Serdexmethylphenidate/dexmethylphenidate is indicated for the treatment of attention deficit hyperactivity disorder in people six years of age and older.[4]

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]

References

  1. ^ a b "Azstarys- serdexmethylphenidate and dexmethylphenidate capsule". DailyMed. Archived from the original on 13 July 2021. Retrieved 13 July 2021.
  2. ^ a b "KemPharm Announces FDA Approval of Azstarys (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), A New Once-Daily Treatment for ADHD" (Press release). KemPharm. 3 March 2021. Archived from the original on 3 March 2021. Retrieved 3 March 2021 – via GlobeNewswire.
  3. ^ McCuistion LE, Yeager JJ, Winton MB, DiMaggio K (2021). "Chapter 18: Stimulants". Pharmacology E-Book: A Patient-Centered Nursing Process Approach. St. Louis, MO: Elsevier Health Sciences. p. 203. ISBN 978-0-323-79316-2. Archived from the original on 9 January 2022. Retrieved 9 January 2022.
  4. ^ a b c d e f g "Drug Trials Snapshots Azstarys". U.S. Food and Drug Administration (FDA). 8 March 2023. Retrieved 8 March 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  5. ^ "Drug Approval Package: Azstarys". U.S. Food and Drug Administration (FDA). 1 April 2021. Retrieved 8 March 2023.


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