Relmada Therapeutics Inc (OTCMKTS:RLMD) reported that Phase I single ascending dose clinical trial with d-Methadone has concluded. It is NMDA receptor antagonist being formulated for the cure of neuropathic pain. The results show that the drug was well tolerated and a MTD was achieved. The company will now commence multiple ascending dose trial in second half of 2015.
The expert speak
Richard Mangano, Ph.D., Senior VP of Clinical Development said that based on the unique method of action, NMDA antagonists have the potential to offer relief from pain and other symptoms resulting due to chronic neuropathic pain. It is a debilitating disorder in which new agents with improved efficacy, tolerability, and long-term safety profiles are required.
The objective
Relmada Therapeutics Inc (OTCMKTS:RLMD) reported that the primary objective of the completed study was to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of oral single ascending doses in healthy subjects so as to establish a MTD. In the second trial, healthy enrollments will be given daily doses of the product for several days depending on the established MTD. The findings from these trials will provide the design of a following Phase II proof of concept trial in neuropathic pain.
The scope
As per Neuropathy Association, neuropathic pain is projected to affect over 20 million people in the U.S. alone. The main categories of drugs utilized to cure neuropathic pain problems are anticonvulsants, antidepressants, topical and opioids treatments. Despite the availability of various pain medications, just 50% of patients respond to available treatment. Relmada’s objective is to reduce clinical development costs and risks while potentially offering valuable products in segment of high unmet medical needs.
In last trading session, the stock price of Relmada surged more than 2% to close the trading session at $1.55. The gains came at a share volume of 136,530 compared to average share volume of 53,871.
