Serdexmethylphenidate/dexmethylphenidate

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Serdexmethylphenidate/dexmethylphenidate
Serdexmethylphenidate 2D Structure.svg
Dexmethylphenidate structure.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]

Related Research Articles

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<span class="mw-page-title-main">Methylphenidate</span> Central nervous system stimulant

Methylphenidate, sold under the brand names Ritalin and Concerta among others, is a potent central nervous system (CNS) stimulant used medically to treat attention deficit hyperactivity disorder (ADHD) and, to a lesser extent, narcolepsy. It is a primary medication for ADHD ; it may be taken by mouth or applied to the skin, and different formulations have varying durations of effect, commonly ranging from 2-4 hours. For ADHD, the effectiveness of methylphenidate is comparable to atomoxetine but modestly lower than amphetamines.

<span class="mw-page-title-main">Dextroamphetamine</span> CNS stimulant and isomer of amphetamine

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Dexmethylphenidate, sold under the brand name Focalin among others, is a potent central nervous system (CNS) stimulant used to treat attention deficit hyperactivity disorder (ADHD) in those over the age of five years. It is taken by mouth. The immediate release formulation lasts up to five hours while the extended release formulation lasts up to twelve hours. It is the more active enantiomer of methylphenidate.

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Viloxazine, sold under the brand name Qelbree and formerly as Vivalan among others, is a selective norepinephrine reuptake inhibitor medication which is used in the treatment of attention deficit hyperactivity disorder (ADHD) in children and adults. It was marketed for almost 30 years as an antidepressant for the treatment of depression before being discontinued and subsequently repurposed as a treatment for ADHD. Viloxazine is taken orally. It was used as an antidepressant in an immediate-release form and is used in ADHD in an extended-release form.

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Lisdexamfetamine, sold under the brand names Vyvanse and Elvanse among others, is a stimulant medication that is used to treat attention deficit hyperactivity disorder (ADHD) in children and adults and for moderate-to-severe binge eating disorder in adults. Lisdexamfetamine is taken by mouth. Its effects generally begin within two hours and last for up to 14 hours. In the United Kingdom, it is usually less preferred to methylphenidate for the treatment of children.

Attention deficit hyperactivity disorder management options are evidence-based practices with established treatment efficacy for ADHD.

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Serdexmethylphenidate is a prodrug of dexmethylphenidate created by the pharmaceutical company KemPharm. The compound was first approved by the FDA as one of the active ingredients in Azstarys for the treatment of attention deficit hyperactivity disorder (ADHD) in children, adolescents, and adults in March 2021. Serdexmethylphenidate is a prodrug which has a delayed onset of action and a prolonged duration of effects compared to dexmethylphenidate, its parent compound.

<span class="mw-page-title-main">Leniolisib</span> Medication

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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. Retrieved 8 March 2023.