Relmada Therapeutics Inc., a company involved in the development of treatments for chronic pain, has announced today that Health Canada has accepted their clinical trial application for two studies designed to test the safety and patient tolerability of the drug D-Methadone, its N-methyl-D-aspartate (NMDA) receptor antagonist for neuropathic pain.
D-Methadone isn't your typical racemic methadone mixture generally dispensed by clinics and treatment centres to treat opiate addiciton. So what is it then? Racemic methadone mixtures contain a 50/50 mix of two isomers; levo-methadone and dextro-methadone, also known as l-methadone and d-methadone. L-Methadone is a full opiate agonist, which produces the typical opiate effects on the brain and
approximately 50 times more potent (yes, 50!) than d-methadone. The d-methadone isomer is completely devoid of opioid activity but acts on the NDMA receptors in the brain.
The clinical trial application was submitted by Relmada Therapeutics Inc. back in September 2014, which was accepted for review by Health Canada. Yesterday, the company excitedly announced that it has received a No Objection Letter (“NOL”) from Health Canada, giving the clearance to commence clinical trials.
So why is Relmada Therapeutics conducting clinical trial on d-methadone when it is completely devoid of opioid activity? There is evidence from nonclinical trials to suggest that NMDA antagonists, such as d-methadone, have the potential to prevent the 'central nervous system changes implicated in maintaining chronic pain states'. To investigate this, in the first trial Relmada will study the safety and tolerability of "single escalating oral doses of d-methadone and determine the maximum tolerated dose for single drug administration" in healthy subjects. The second trial will investigate the safety and tolerability of "daily multiple escalating oral doses of d-methadone for the assessment of safety and tolerability."
Along with the news that Relmada had received a 'No Objection Letter' from Health Canada, the company released the following statement:
“We are extremely pleased to have completed this milestone as we continue to make progress with the development of our chronic pain relief solutions,” stated Sergio Traversa, CEO of Relmada Therapeutics. “There is a huge potential market for a treatment that can address neuropathic pain. If we can demonstrate that d-methadone has analgesic efficacy in this painful condition, we strongly believe that it has the potential to be a blockbuster drug in this large and unsatisfied market."
Relmada CEO Sergio Traversa believes that the development of such a product devoid of opioid activity could be helpful in reducing abuse and addiction in the treatment of neuropathic pain. In addition to the clinical trials on d-methadone, Relmada is also developing several other opioid products, such as LevoCap ER, BuTab ER, and MepiGel.
By K. Lanktree
- Freelance Writer -
- Blog Mistress -
- Former IV Drug User -
- Methadone Patient -
- Lover of all things Harm Reduction -
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