Serdexmethylphenidate/dexmethylphenidate

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Serdexmethylphenidate/dexmethylphenidate
Dexmethylphenidate and serdexmethylphenidate.svg
Combination of
Serdexmethylphenidate Prodrug of dexmethylphenidate
Dexmethylphenidate Catecholamine reuptake inhibitor
Clinical data
Trade names Azstarys
Other namesKP415
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]

Contents

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

52.3 mg/10.4 mg Azstarys capsules Azstarys-52 3-10 4-capsules.jpg
52.3 mg/10.4 mg Azstarys capsules

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. 1 2 "Azstarys- serdexmethylphenidate and dexmethylphenidate capsule". DailyMed. Archived from the original on 13 July 2021. Retrieved 13 July 2021.
  2. 1 2 "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. 1 2 3 4 5 6 7 "Drug Trials Snapshots Azstarys". U.S. Food and Drug Administration (FDA). 8 March 2023. Retrieved 8 March 2023.PD-icon.svg 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. Archived from the original on 3 May 2021. Retrieved 8 March 2023.