Overcoming Tramadol Resistance In CYP2D6 Poor Metabolizers:A Phase 1 Trial Demonstrating Analgesic Superiority of Omnitram to Tramadol in Subjects Coadministered Paroxetine

DESCRIPTIONprovided by applicantFromthe utilization of the Schedule II opioids codeineOxyContin and fentanyl declined significantlydown aboutfor all three drugsIn sharp contrastthe use of tramadola Schedule IV controlled substanceincreasedSchedule IV substances have low potential for abuse and harm relative to Schedule II substancesand the fortuitous trend to tramadol has reduced the use of the relatively unsafe Schedule II opioids dramaticallyTramadol is a weak opioid adjunct combination that is recognized as having a better safety profile and less abuse potential than Schedule II opioidse goxycodonetapentadolUnfortunatelytramadol suffers from a critical shortcomingTramadol requires metabolic activation for efficacyand individuals who are CYP Dpoor metabolizersPMsfail to obtain pain reliefThe "real world" incidence of CYP DPM status in clinical practice has been shown to be as high asinTramadol resistance due to CYP DPM status is a shortcoming that results in a significant negative impact on patient careand that erodes the entire utility of tramadol as a safer alternative to Schedule II opioidsThere exists a significant need for an "improved tramadol" that would have the same inherent safety but be effective in all patients irrespective of their metabolic statusOmnitram is a novel mixed mechanism analgesic developed by Syntrix that is an opioid adjunct analgesic combination consisting of the enantiomers of O desmethyltramadolthe active metabolite of tramadolOmnitram provides the same net pharmacology as tramadolbut in contrast to tramadoldoes not require metabolism by CYP Dfor its activityOmnitram broadly increases the utility of tramadoland would leverage and accelerate the shift in prescribing trends away from the relatively unsafe Schedule II opioidsThis proposal aims to demonstrate that Omnitram analgesia is superior to tramadol analgesia in otherwise healthy CYP Ddeficient subjectsSuccess in this in patient Phaseb clinical trial will provide direct support for Omnitram s advantages in clinical pain states in CYP Ddeficient patients