Serdexmethylphenidate
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Other names | SDX | |
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Routes of administration | By mouth | |
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Serdexmethylphenidate is a
Medical uses
The combination serdexmethylphenidate/dexmethylphenidate (Azstarys) was approved by the Food and Drug Administration (FDA) in March 2021, for the treatment of ADHD in people six years of age and older.[2] Co-formulation of serdexmethylphenidate with dexmethylphenidate allows for a more rapid onset of action while still retaining up to 13 hours of therapeutic efficacy.[4][5]
Society and culture
Abuse potential
The abuse potential of serdexmethylphenidate has been evaluated in clinical studies.[6] Administration of serdexmethylphenidate via common routes of administration used during the abuse of psychostimulants such as insufflation and intravenous injection resulted in significantly reduced systemic exposure to active dexmethylphenidate and thus markedly decreased pharmacodynamic effects when compared to unmodified dexmethylphenidate.[7]
Following an Eight Factor Analysis by the FDA Controlled Substance Staff (CSS), the
Research
Due to the delayed onset and prolonged duration of effects following oral administration of serdexmethylphenidate, several dosage forms containing serdexmethylphenidate are under investigation for use as long-acting
In January 2021, the FDA granted approval for clinical trials investigating serdexmethylphenidate (as KP879) for the treatment for stimulant use disorder.[9]
See also
- Lisdexamfetamine, a prodrug to dextroamphetamine known under the brands Vyvanse, Elvanse and others
References
- ^ a b "Schedules of Controlled Substances: Placement of Serdexmethylphenidate in Schedule IV". Federal Register. 24 June 2022. Retrieved 13 April 2023.
- ^ a b c d "Azstarys- serdexmethylphenidate and dexmethylphenidate capsule". DailyMed. 3 November 2022. Retrieved 13 April 2023.
- ^ KemPharm (3 March 2021). "KemPharm Announces FDA Approval of Azstarys (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), A New Once-Daily Treatment for ADHD" (Press release). KemPharm. Retrieved 17 May 2021 – via GlobeNewswire.
- ^ Mickle T. "Prodrugs for ADHD Treatments: Opportunities & Potential to Fill Unmet Medical Needs" (PDF). Archived from the original (PDF) on 21 November 2020. Retrieved 15 November 2020.
- ^ Bastings E (2 March 2021). "NDA 212994 Approval" (PDF). U.S. Food and Drug Administration (FDA). Retrieved 6 March 2021.
- ^ a b "Schedules of Controlled Substances: Placement of Serdexmethylphenidate in Schedule IV". Federal Register. 7 May 2021. Retrieved 17 May 2021.
- S2CID 149510614. Retrieved 15 November 2020.
- ^ a b "Pipeline & Products". Kempharm Inc. Archived from the original on 17 May 2021. Retrieved 17 May 2021.
- ^ "KemPharm Receives FDA Clearance to Initiate KP879 Clinical Program for the Treatment of Stimulant Use Disorder" (Press release). KemPharm. 27 January 2021. Retrieved 23 April 2021 – via GlobeNewswire News Room.