Oral, intranasal, and intravenous abuse potential of serdexmethylphenidate, a novel prodrug of d-methylphenidate

Serdexmethylphenidate (SDX) chloride (Cl) is a novel prodrug of d-methylphenidate (d-MPH). These studies evaluated the abuse potential of SDX Cl when administered orally, intranasally (IN), and intravenously (IV). Three randomized, double-blind, placebo- and active-controlled crossover studies were...

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Bibliographic Details
Published in:Current medical research and opinion 2022-07, Vol.38 (7), p.1237-1250
Main Authors: Shram, Megan J., Setnik, Beatrice, Webster, Lynn, Guenther, Sven, Mickle, Travis C., Braeckman, Rene, Kanski, Jaroslaw, Martin, Andrea, Kelsh, Debra, Vince, Bradley D., Barrett, Andrew C.
Format: Article
Language:English
Subjects:
Attention-deficit/hyperactivity disorder (ADHD)
d-methylphenidate
human abuse potential
serdexmethylphenidate (SDX)
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Summary:Serdexmethylphenidate (SDX) chloride (Cl) is a novel prodrug of d-methylphenidate (d-MPH). These studies evaluated the abuse potential of SDX Cl when administered orally, intranasally (IN), and intravenously (IV). Three randomized, double-blind, placebo- and active-controlled crossover studies were conducted in recreational drug users to evaluate the abuse-related effects of oral SDX (120 and 240 mg) vs. extended-release (ER) d-MPH (80 mg) and phentermine (60 mg); IN SDX (80 mg) vs. d-MPH (40 mg), and IV SDX (30 mg) vs. d-MPH (15 mg). Abuse-related subjective measures, pharmacokinetics, and safety were assessed. The primary endpoint of maximum (E max ) Drug Liking (DL) (0-100-point scale) was significantly higher following d-MPH vs. placebo, validating the studies. In the oral study, DL E max was significantly higher following 80 mg ER d-MPH (E max = 81.5) than 120 mg SDX (E max = 62.8, p 
ISSN:0300-7995
1473-4877
DOI:10.1080/03007995.2022.2076474