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news.US-based Relmada Therapeutics has completed a Phase I single ascending dose (SAD) clinical trial of its new N-methyl-D-aspartate (NMDA) receptor antagonist, d-Methadone (dextromethadone, REL-1017), for the treatment of neuropathic pain.
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Results from the trial show that d-Methadone was generally well tolerated and a maximum tolerated dose (MTD) was achieved.
The company said that the planned multiple ascending dose (MAD) trial with d-Methadone will begin in the second half of this year.
Upon successful completion of the MAD trial, d-Methadone will be eligible to enter Phase II clinical development in the first half of next year.
Relmada Therapeutics clinical development senior vice-president Richard Mangano said: "Based on their unique mechanism of action, NMDA antagonists such as d-Methadone have the potential to provide relief of pain and other symptoms in patients suffering from chronic neuropathic pain, a debilitating disorder in which novel agents with improved tolerability, efficacy, and long-term safety profiles are needed."
The Phase I SAD trial was designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of oral single ascending doses of d-Methadone in healthy subjects in order to establish a MTD.
In the planned MAD trial, healthy subjects will receive daily doses of the product over several days based on the established MTD.
Data from these trials will inform the design of a subsequent Phase II proof of concept study in neuropathic pain.
The company said that as a single isomer, d-Methadone has been shown to possess NMDA antagonist properties with virtually no opioid activity at the expected therapeutic doses.