AUBURN, Wash./PRNewswire/ -- Syntrix Pharmaceuticals today announced the initiation of a Phase 2 study evaluating the efficacy and safety of desmetramadol for the treatment of diabetic neuropathic pain. Desmetramadol promises to provide a critically needed improvement to both tramadol (schedule IV) and the more dangerous and abuse-prone schedule II narcotics now at the center of the U.S. Opioid Crisis. Nearly 20 patients are on study.
With over 40 million prescriptions per year, tramadol is immensely popular in the U.S. where it is seen as a less-abused and safer alternative to schedule II narcotics that cause respiratory depression even at therapeutic doses. However, tramadol suffers from requiring metabolic activation in the body to the active metabolite in order for it to work. Up to half of patients cannot optimally metabolize tramadol due to their genetics or interactions with co-prescribed drugs. The FDA tramadol label contains "black box" warnings of these metabolic liabilities and their adverse effects on its efficacy in poor metabolizers and safety in ultra-rapid metabolizers.
Desmetramadol is a patented composition that eliminates these metabolic liabilities by delivering the active tramadol metabolite directly without the need for metabolic activation.
"We are excited to advance our development of desmetramadol, which has the potential to replace tramadol, the second most prescribed analgesic in the U.S., and perhaps substitute for dangerous schedule II opioids," said John Zebala, MD, PhD, President of Syntrix. "Neuropathic pain is particularly difficult to treat and patients are often given anti-depressants that potently inhibit metabolic activation of tramadol. Desmetramadol is a novel solution around this issue."
This phase 2 multi-center trial is a double-blind, randomized, placebo-controlled cross-over study designed to evaluate the efficacy and safety of desmetramadol in approximately 50 patients with diabetic neuropathy. The primary endpoint is the patient rated pain intensity after four weeks of treatment with either placebo or desmetramadol. Support for the trial is from the National Institute on Drug Abuse (NIDA).
ABOUT DESMETRAMADOL: Desmetramadol (Omnitram prior working name) is the racemic active metabolite of tramadol that delivers both a mu-opioid receptor agonist and an inhibitor of norepinephrine reuptake. The combined activities provide synergistic pain relief. Desmetramadol is poised to enter phase 3 testing in acute pain. Desmetramadol was developed by Syntrix with support from the National Institute on Drug Abuse (NIDA).
ABOUT SYNTRIX: Syntrix is a pharmaceutical company committed to discovering and delivering innovative therapies to solve the most difficult clinical problems. Convergent Science & Strategy. Breakthrough Medicines.
DISCLOSURE NOTICE: This release contains forward-looking information that is based on company management's current beliefs and expectations and are subject to currently unknown information, risks and circumstances. Actual results may vary from what is projected. Syntrix does not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.
Media Contact: Aaron Schuler, PhD, 253-833-8009, x21