Serdexmethylphenidate/dexmethylphenidate isindicated for the treatment of attention deficit hyperactivity disorder in people six years of age and older.[4]
When administered orally in a 70:30 molar ratio, serdexmethylphenidate/dexmethylphenidate produces a dexmethylphenidate plasma concentration profile with a time to maximum concentration Tmax of approximately 2 hours and an mean terminal elimination half-life of 11.7 hours.[6]
The USFood 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]
^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.ISBN978-0-323-79316-2.Archived from the original on 9 January 2022. Retrieved9 January 2022.
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