US-based Relmada Therapeutics has completed its multiple ascending dose (MAD) study with d-Methadone (dextromethadone, REL-1017), a new treatment for neuropathic pain.
The MAD study was designed to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of oral multiple ascending doses of d-Methadone.
Healthy subjects were given daily doses of d-Methadone over ten days. The dose sizes were based on the dose range and maximum tolerated dose established in the company's Phase I single ascending dose (SAD) study.
The results successfully showed a potential therapeutic dosing regimen for d-Methadone, with a favourable side effect and tolerability profile.
In March 2015, the company completed a SAD study, findings from which will dictate the design of its Phase II proof-of-concept study in neuropathic pain, which is expected to be initiated in the first half of this year.
Relmada Therapeutics CEO Sergio Traversa said: "The results from the MAD study further build on the positive results seen in the previous clinical trial of d-Methadone, as they confirm and extend the safety and tolerability observed in our previously completed SAD study.
"Given the high level of need for more effective and better-tolerated therapies for chronic neuropathic pain, we remain committed to advancing d-Methadone with the goal of providing a novel treatment option with virtually no opioid-related adverse effects for patients suffering from a wide range of pain syndromes."
A single isomer, d-Methadone is a N-methyl-D-aspartate (NMDA) receptor antagonist. It has been shown to possess NMDA antagonist properties with virtually no opioid activity at the expected therapeutic doses.
The company noted that the activation of NMDA receptors has been associated with neuropathic pain, and it is expected that d-Methadone will have a role in pain management by blocking this activity.
Dr Traversa added: "The d-Methadone findings announced today, together with the recently announced positive BuTab results, strongly affirm Relmada's robust product development pipeline and the many value creation opportunities that are possible over the next 12 to 24 months.
"We believe that we have the right Board, management team and strategy in place to realise these opportunities and remain focused on the continued development of our product portfolio, which we expect to create benefits for patients and Relmada stockholders alike."