Oral, intranasal, and intravenous abuse potential of serdexmethylphenidate, a novel prodrug of d-methylphenidate
Source : https://www.tandfonline.com/doi/full/10.1080/03007995.2022.2076474
Abstract Abstract 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.
Conclusions: These findings indicate that the novel d-MPH prodrug, SDX, has lower abuse potential than d-MPH and support its classification as a C-IV controlled substance.
• Source: Current Medical Research and Opinion
• Conclusion: “These findings indicate that the novel d-MPH [d-methylphenidate] prodrug, SDX [serdexmethylphenidate], has lower abuse potential than d-MPH and support its classification as a C-IV controlled substance.”
• In the current study, Canadian and U.S. researchers assessed the abuse potential of SDX CL after oral, intranasal, and intravenous administration. They mined results from 3 randomized, placebo- and active-control crossover studies among recreational drug users.
• “For all 3 routes of administration, SDX Cl was associated with lower abuse potential than d-MPH HCl comparators as evidenced by statistically significantly lower abuse-related effects in PD assessments (including the primary endpoint, Drug Liking Emax) and fewer stimulant-like AEs (e.g. euphoric mood, hypervigilance, palpitations),” the authors state,
• SDX was classified as a Schedule IV substance based on the results of this study, with lower abuse potential than that of d-MPH.
• Although the design and outcomes of this study meet requirements for abuse potential, there were certain limitations. For instance, real-world abuse potential of SDX vs. d-MPH was not assessed. Additionally, the researchers looked at subjective and not objective measures (e.g., drug self-administration).