Syntrix Clinical Trial of Omnitram Succeeds on Primary Endpoints

Syntrix Clinical Trial of Omnitram Succeeds on Primary Endpoints
May 12, 2015 Syntrix

Syntrix announced that the Phase 1B study investigating Omnitram for pain in healthy subjects met its primary endpoints for pharmacokinetics, safety, and analgesia.  The study was performed with Syntrix collaborators at PRA International and the IIT Research Institute.  The study was funded by a $1.8 million grant from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH).  Omnitram targets the existing world opioid and tramadol markets with a “better” tramadol. Tramadol analgesia depends on its metabolism to an active product (O-desmethyltramadol); the metabolism is highly variable and is affected by patient genetics, diet, and concomitant medications, and results in many treatment failures.  Omnitram is a novel innovative formulation that provides the active O-desmethyltramadol metabolite to patients in a highly reliable and consistent fashion.  The Phase 1B trial demonstrated that Omnitram was safe and had similar efficacy to tramadol in the cold pressor test.  Furthermore, during Omnitram administration the volunteers had consistent therapeutic steady state blood concentrations of O-desmethyltramadol regardless of their metabolic genotype, unlike what was observed in subject plasma during tramadol administration, where the O-desmethyltramadol concentrations varied with the metabolic genotype of the volunteers.  These results strongly support the continued development of Omnitram for the treatment of acute and chronic pain.


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