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methylphenidate + naltrexone
- Development stage
- Phase 1
- Lead developer
- Avekshan
- Modality
- Small Molecules
- Administration
- Oral
01
Overview
AVK-001 (methylphenidate + naltrexone) is an investigational fixed-dose combination (FDC) therapy being developed by Avekshan LLC for the treatment of attention-deficit/hyperactivity disorder (ADHD), specifically aimed at reducing the risk of stimulant misuse and diversion. Methylphenidate is a well-established central nervous system (CNS) stimulant that acts as a norepinephrine-dopamine reuptake inhibitor (NDRI). While effective for ADHD, methylphenidate can activate μ-opioid receptors at high doses, leading to euphoria and reinforcing its potential for abuse. Naltrexone is a non-selective opioid receptor antagonist added to the formulation to block these μ-opioid receptors. By attenuating the euphoric "liking" effects associated with supra-therapeutic doses, the combination is designed to maintain the clinical efficacy of methylphenidate for ADHD symptoms while significantly lowering its abuse liability. The product is being developed via the 505(b)(2) regulatory pathway.
- Other names
- Methylphenidate/naltrexone
02
Targets
DAT (Dopamine plasma membrane transport protein)NET (Norepinephrine Transporter)MOR (Mu opioid receptor)DOR (Opioid Receptor Delta 1)KOR (Kappa opioid receptor)
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