Relmada Therapeutics Inc (OTCMKTS:RLMD) disclosed that Phase 1 “single ascending dose” study with d-Methadone has ended. It can be defined as an NMDA receptor antagonist being designed as a medication for neuropathic pain. The findings validate that the medication was well tolerated and also a MTD was accomplished. The company intends to start multiple ascending dose study in coming quarters of 2015.
The expert comments
Richard Mangano, Ph.D. who is Senior VP of Clinical Development expressed that considering the method of action, it is evident NMDA antagonists possess the ability to offer relief from neuropathic pain and other symptoms associated with chronic neuropathic problems. It is a major problem area which requires new treatment options with better effectiveness, tolerability, and safety profile.
The company revealed that the primary goal of the ended trial was to evaluate the pharmacokinetics, pharmacodynamics, tolerability and safety of oral single ascending medications in healthy enrollments to achieve a MTD. Now, in the second planned trial, healthy subjects will be administered with daily doses for several days, largely based on the set MTD. The study results will give the design of next Phase II proof of concept experiment in neuropathic pain.
As per Neuropathy Association, the problem of neuropathic pain is likely to affect over twenty million individuals in the U.S. alone. As of now, the treatment options available are anticonvulsants, antidepressants, opioids and topical medications. The problem is despite the availability of large number of pain medications, merely 50% of people respond to given treatment. The company‘s goal is to reduce clinical development expenses and perils while potentially launching valuable products in market of high unmet medical needs.
In last trading session, the stock price of Relmada gained more than 4% to close the trading session at $1.95. The gains came at a share volume of 120,023 compared to average share volume of 64,510.