FDA Grants Orphan Drug Designation for Neuropathic Condition

The FDA recently granted Orphan Drug Designation to d-Methadone (dextromethadone, REL-1017) for the treatment of postherpetic neuralgia, which is a neuropathic condition from an outbreak of shingles.

The drug is a N-methyl-d-aspartate (NMDA) receptor antagonist currently being developed to treat depression and chronic neuropathic pain, according to a press release from Relmada Therapeutics, Inc. In the study, researchers analyzed whether d-Methadone had antidepressant-like effects after 1 dose in an animal model.

Researchers found that d-Methadone decreased immobility of the animal models compared with the control group. They also discovered that the largest doses in d-Methadone elicited more mobility than ketamine, according to the study.

"The award of Orphan Drug designation for d-Methadone in the treatment of neuropathic pain is another important development in our ongoing efforts to advance this highly promising therapy to late stage clinical development and regulatory review," said Sergio Traversa, CEO of Relmada Therapeutics. "We continue to see promising results in our research with d-Methadone in neuropathic pain as we also work to advance our development plans for this compound in the treatment of depression."