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news.US-based Relmada Therapeutics has received clearance from Health Canada to conduct a multiple ascending dose (MAD) clinical study with d-Methadone (REL-1017 dextromethadone), its new N-methyl-D-aspartate (NMDA) receptor antagonist being developed to treat neuropathic pain.
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The NMDA receptor helps in the transfer of electrical signals between neurons in the brain and in the spinal column.
Initial results from the company’s completed single ascending dose study showed a potentially therapeutic dose range for d-Methadone without the side effects typically observed with racemic methadone in opioid naive subjects or with other NMDA inhibitors, such as ketamine.
The single ascending dose study was aimed at evaluating the safety, tolerability, pharmacodynamics and pharmacokinetics of oral single ascending doses of d-Methadone in healthy subjects in order to establish a Maximum Tolerated Dose (MTD).
The company noted that in the planned second study, healthy subjects will receive daily doses of the product over several days based on the established MTD.
Following successful completion of the MAD study, d-Methadone will enter Phase II proof of concept clinical development in the first half of next year.