Syntrix Receives $2.965M Grant to Conduct a Phase Ib Clinical Trial Investigating Omnitram for the treatment of Pain in patients resistant to Tramadol

Syntrix Receives $2.965M Grant to Conduct a Phase Ib Clinical Trial Investigating Omnitram for the treatment of Pain in patients resistant to Tramadol
August 22, 2016 Syntrix

Syntrix announced today the award of a $2.965 million grant from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH) to perform a clinical study investigating Omnitram for the treatment of pain in patients resistant to Tramadol.

Omnitram is a new opioid-sparing opioid-adjunct drug combination that is predicted to have low abuse potential.  It consists of an innovative formulation that delivers the active racemic analgesic metabolite of tramadol (O-desmethyltramadol) without requiring metabolism by cytochrome P450 2D6 (CYP2D6) for its activity.  Omnitram consists of the (−) and (+) enantiomers of O-desmethyltramadol.  The (+)-enantiomer is a weak μ-opioid receptor agonist, while the (-)-enantiomer (the adunct) is a norepinephrine reuptake inhibitor that synergizes with the (+)-enantiomer. Individuals who are CYP2D6 poor metabolizers fail to obtain pain relief from tramadol, because they cannot metabolize tramadol to the active O-desmethylatramadol metabolite.  The “real world” incidence of CYP2D6 poor metabolizer status in patients on polypharmacotherapy is as high as 1 in 3.  Omnitram is therefore an opportunity to develop an “improved tramadol” that is effective in all patients, irrespective of their CYP2D6 metabolic status and free of drug-drug interactions from other co-prescribed medications.  Omnitram successfully completed a Phase 1b randomized, double-blind, placebo-controlled trial that demonstrated Omnitram provided significant analgesia compared to placebo in an experimental pain model in healthy subjects.  The recently awarded grant aims to further the success of the Omnitram program by further demonstrating that analgesic efficacy is maintained with Omnitram (but not with tramadol) in subjects phenoconverted into poor metabolizers by concomitant dosing with an antidepressant medication that powerfully inhibits CYP2D6.

Read about Omnitram in our pipeline.  www.syntrixbio.com

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