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Ond-PR1 + MPh-IR is an investigational combination drug therapy developed by Tong Lee (Tong Lee Pharmaceutical) for the treatment of psychostimulant use disorder (PUD). The therapy consists of two active components: (1) Ond-PR1, a novel pulsatile-release formulation of the serotonin 5-HT3 receptor antagonist ondansetron, and (2) MPh-IR, an immediate-release formulation of the dopamine and norepinephrine reuptake inhibitor methylphenidate. The rationale for this combination is to achieve a temporally staggered pharmacokinetic profile from a single simultaneous administration, mimicking a regimen where the two drugs are taken several hours apart. This design is intended to target the dysfunctional neural processes underlying stimulant addiction while improving patient treatment compliance. The development of this formulation was supported by NIH grant RC2 DA028905 and has been evaluated in Phase Ia/Ib clinical trials to determine the safety, tolerability, and pharmacokinetic interactions between the novel ondansetron formulation and methylphenidate.
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