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{{Short description|A combination of CNS Stimulants}}
{{Distinguish|serdexmethylphenidate}}
{{Use American English|date=March 2021}}
{{Use American English|date=March 2021}}
{{Use dmy dates|date=March 2021}}
{{Use dmy dates|date=March 2021}}
{{Infobox drug
{{Infobox drug
| drug_name =
| drug_name =
| type = combo
| type = combo
| image = Serdexmethylphenidate 2D Structure.svg
| image = Dexmethylphenidate and serdexmethylphenidate.svg
| width = 200px
| width = 250
| alt =
| caption =
| image2 = Dexmethylphenidate structure.svg
| width2 = 100px
| alt2 =
| caption =


<!-- Combo data -->
<!-- Combo data -->
| component1 = Serdexmethylphenidate
| component1 = Serdexmethylphenidate
| class1 = [[Catecholamine]] [[reuptake inhibitor]]
| class1 = [[Prodrug]] of [[dexmethylphenidate]]
| component2 = Dexmethylphenidate
| component2 = Dexmethylphenidate
| class2 = Catecholamine reuptake inhibitor
| class2 = Catecholamine reuptake inhibitor


<!-- Clinical data -->
<!-- Clinical data -->
| tradename = Azstarys
| tradename = Azstarys
| Drugs.com =
| Drugs.com = {{drugs.com|cons|serdexmethylphenidate-and-dexmethylphenidate}}
| MedlinePlus =
| MedlinePlus =
| licence_CA = <!-- Health Canada may use generic or brand name (generic name preferred) -->
| licence_CA = <!-- Health Canada may use generic or brand name (generic name preferred) -->
| licence_EU = <!-- EMA uses INN (or special INN_EMA) -->
| licence_EU = <!-- EMA uses INN (or special INN_EMA) -->
| DailyMedID = Azstarys
| DailyMedID = Azstarys
| licence_US = <!-- FDA may use generic or brand name (generic name preferred) -->
| licence_US = <!-- FDA may use generic or brand name (generic name preferred) -->
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_AU_comment =
| pregnancy_AU_comment =
| pregnancy_category=
| pregnancy_category =
| dependency_liability =
| dependency_liability =
| addiction_liability =
| addiction_liability =
| routes_of_administration =
| routes_of_administration = [[Oral administration|By mouth]]
| ATCvet =
| ATCvet =
| ATC_prefix = None
| ATC_prefix = N06
| ATC_suffix =
| ATC_suffix = BA15
| ATC_supplemental =
| ATC_supplemental =


<!-- Legal status -->
<!-- Legal status -->
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled -->
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled -->
| legal_AU_comment =
| legal_AU_comment =
| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F -->
| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F -->
| legal_BR_comment =
| legal_BR_comment =
| legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII -->
| legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII -->
| legal_CA_comment =
| legal_CA_comment =
| legal_DE = <!-- Anlage I, II, III or Unscheduled -->
| legal_DE = <!-- Anlage I, II, III or Unscheduled -->
| legal_DE_comment =
| legal_DE_comment =
| legal_NZ = <!-- Class A, B, C -->
| legal_NZ = <!-- Class A, B, C -->
| legal_NZ_comment =
| legal_NZ_comment =
| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM / Class A, B, C -->
| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM / Class A, B, C -->
| legal_UK_comment =
| legal_UK_comment =
| legal_US = Rx-only
| legal_US = Schedule II
| legal_US_comment = <ref name="Azstarys FDA label">{{cite web|title=Azstarys- serdexmethylphenidate and dexmethylphenidate capsule|website=DailyMed|url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=00b5e716-5564-4bbd-acaf-df2bc45a5663|access-date=13 July 2021|archive-date=13 July 2021|archive-url=https://web.archive.org/web/20210713141416/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=00b5e716-5564-4bbd-acaf-df2bc45a5663|url-status=live}}</ref>
| legal_US_comment =
| legal_EU =
| legal_EU =
| legal_EU_comment =
| legal_EU_comment =
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV -->
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV -->
| legal_UN_comment =
| legal_UN_comment =
| legal_status = <!-- For countries not listed above -->
| legal_status = <!-- For countries not listed above -->


<!-- Identifiers -->
<!-- Identifiers -->
| CAS_number_Ref =
| CAS_number_Ref =
| CAS_number =
| CAS_number =
| CAS_supplemental =
| CAS_supplemental =
| PubChem =
| PubChem =
| IUPHAR_ligand =
| IUPHAR_ligand =
| DrugBank_Ref =
| DrugBank_Ref =
| DrugBank =
| DrugBank =
| ChemSpiderID_Ref =
| ChemSpiderID_Ref =
| ChemSpiderID =
| ChemSpiderID =
| UNII_Ref =
| UNII_Ref =
| UNII =
| UNII =
| KEGG_Ref =
| KEGG_Ref =
| KEGG =
| KEGG = D11989
| ChEBI_Ref =
| ChEBI_Ref =
| ChEBI =
| ChEBI =
| ChEMBL_Ref =
| ChEMBL_Ref =
| ChEMBL =
| ChEMBL =
| NIAID_ChemDB =
| NIAID_ChemDB =
| PDB_ligand =
| PDB_ligand =
| synonyms = KP415
| synonyms = KP415

<!-- Chemical and physical data -->
}}
}}
⚫
'''Serdexmethylphenidate/dexmethylphenidate''', sold under the brand name '''Azstarys''', is a [[fixed-dose combination]] [[medication]] used to treat [[attention deficit hyperactivity disorder]] (ADHD) in people aged six years and older.<ref name="KemPharm PR">{{cite press release | title=KemPharm Announces FDA Approval of Azstarys (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), A New Once-Daily Treatment for ADHD | publisher=KemPharm | via=GlobeNewswire | date=3 March 2021 | url=http://www.globenewswire.com/news-release/2021/03/03/2185820/0/en/KemPharm-Announces-FDA-Approval-of-AZSTARYS-serdexmethylphenidate-and-dexmethylphenidate-capsules-for-oral-use-CII-A-New-Once-Daily-Treatment-for-ADHD.html | access-date=3 March 2021}}</ref>


⚫
'''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.<ref name="Azstarys FDA label" /><ref name="KemPharm PR">{{cite press release|title=KemPharm Announces FDA Approval of Azstarys (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), A New Once-Daily Treatment for ADHD|publisher=KemPharm|via=GlobeNewswire|date=3 March 2021|url=http://www.globenewswire.com/news-release/2021/03/03/2185820/0/en/KemPharm-Announces-FDA-Approval-of-AZSTARYS-serdexmethylphenidate-and-dexmethylphenidate-capsules-for-oral-use-CII-A-New-Once-Daily-Treatment-for-ADHD.html|access-date=3 March 2021|archive-date=3 March 2021|archive-url=https://web.archive.org/web/20210303043638/https://www.globenewswire.com/news-release/2021/03/03/2185820/0/en/KemPharm-Announces-FDA-Approval-of-AZSTARYS-serdexmethylphenidate-and-dexmethylphenidate-capsules-for-oral-use-CII-A-New-Once-Daily-Treatment-for-ADHD.html|url-status=live}}</ref><ref>{{cite book|vauthors=McCuistion LE, Yeager JJ, Winton MB, DiMaggio K|chapter=Chapter 18: Stimulants|title=Pharmacology E-Book: A Patient-Centered Nursing Process Approach|date=2021|location=St. Louis, MO|publisher=Elsevier Health Sciences|isbn=978-0-323-79316-2|page=203|chapter-url=https://books.google.com/books?id=9HVWEAAAQBAJ&pg=PA203|access-date=9 January 2022|archive-date=9 January 2022|archive-url=https://web.archive.org/web/20220109123957/https://books.google.com/books?id=9HVWEAAAQBAJ&pg=PA203|url-status=live}}</ref>
It was approved for medical use in the United States in March 2021.<ref name="KemPharm PR" />

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.<ref name="Drug Trials Snapshots Azstarys" />

It was approved for medical use in the United States in March 2021.<ref name="Drug Trials Snapshots Azstarys" /><ref>{{cite web | title=Drug Approval Package: Azstarys | website=U.S. [[Food and Drug Administration]] (FDA) | date=1 April 2021 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/212994Orig1s000TOC.cfm | access-date=8 March 2023}}</ref><ref name="KemPharm PR" />

== Medical uses ==
[[File:Azstarys-52 3-10 4-capsules.jpg|thumb|52.3&nbsp;mg/10.4&nbsp;mg Azstarys capsules]]

Serdexmethylphenidate/dexmethylphenidate is [[indicated]] for the treatment of attention deficit hyperactivity disorder in people six years of age and older.<ref name="Drug Trials Snapshots Azstarys">{{cite web | title=Drug Trials Snapshots Azstarys | website=U.S. [[Food and Drug Administration]] (FDA) | date=8 March 2023 | url=https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-azstarys | access-date=8 March 2023}} {{PD-notice}}</ref>

== 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).<ref name="Drug Trials Snapshots Azstarys" /> The four-week trial was conducted at five sites in the United States.<ref name="Drug Trials Snapshots Azstarys" /> 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).<ref name="Drug Trials Snapshots Azstarys" /> The 12-month trial was conducted at 18 sites in the United States.<ref name="Drug Trials Snapshots Azstarys" />


== References ==
== References ==
{{reflist}}
{{reflist}}


{{Psychostimulants, agents used for ADHD and nootropics}}
== External links ==
{{ADHD pharmacotherapies}}
* {{cite web | url = https://druginfo.nlm.nih.gov/drugportal/name/serdexmethylphenidate | publisher = U.S. National Library of Medicine | work = Drug Information Portal | title = Serdexmethylphenidate }}
{{Monoamine reuptake inhibitors}}
* {{cite web | url = https://druginfo.nlm.nih.gov/drugportal/name/dexmethylphenidate | publisher = U.S. National Library of Medicine | work = Drug Information Portal | title = Dexmethylphenidate }}

{{Portal bar | Medicine}}
{{Portal bar | Medicine}}


{{DEFAULTSORT:Serdexmethylphenidate Dexmethylphenidate}}
{{nervous-system-drug-stub}}
[[Category:Combination psychiatric drugs]]
[[Category:Methylphenidate]]
[[Category:Norepinephrine–dopamine reuptake inhibitors]]
[[Category:Stimulants]]

Latest revision as of 16:04, 16 October 2024

Not to be confused with serdexmethylphenidate.

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

[edit]
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

[edit]

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

[edit]
  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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