A clinical study of a multiple ascending dose (MAD) of d-Methadone and N-methyl-D-aspartate (“NMDA”) receptor antagonist for neuropathic pain was completed by Relmada Therapeutics (OTCQB: RLMD). The study’s conclusion marks what is anticipated to be the start of a Phase II clinical study for neuropathic pain beginning in 2016.
“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,” said Sergio Traversa, CEO of Relmada Therapeutics in a news release.
“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,” Traversa added.
The study’s goal was to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of oral multiple ascending doses of d-Methadone in healthy subjects. Study participants received daily doses of d-Methadone over ten days. The results showed a target therapeutic dosing regimen that keeps side effects in check while being tolerable, the company said.
d-Methadone (REL-1017) possesses NMDA antagonist properties with virtually no opioid activity at the therapeutic doses. The activation of NMDA receptors is associated with neuropathic pain. The company expects that REL-1017 will have a role in pain management by blocking this activity.
The company notes that REL-1017 contrasts with racemic methadone, which is a long-acting narcotic producing typical opioid side effects when used to treat pain, or as a substitution therapy in opioid addiction.