Phase II clinical evaluation of Omnitram in neuropathic pain

DESCRIPTION provided by applicant Neuropathic pain is caused by damage to the peripheral nerves as occurs in diabetic neuropathy Neuropathic pain is difficult to treat and many patients have pain that is refractory to existing treatments Omnitram is a novel mixed mechanism analgesic developed by Syntrix that consists of the and enantiomers of O desmethyltramadol The enantiomer is a potent opioid receptor agonist while the enantiomer is a norepinephrine reuptake inhibitor that synergizes with the enantiomer Omnitram is inherently an opioid sparing opioid adjuvant combination therapy that is predicted to have low abuse potential O desmethyltramadol is the primary metabolite M of tramadol Omnitram provides the same net pharmacology as tramadol but in contrast to tramadol does not require metabolism by cytochrome P D CYP D for its activity i e it is metabolism independent Individuals who are CYP D poor metabolizers PMs fail to obtain pain relief from tramadol The andquot real worldandquot incidence of CYP D PM status in patients on polypharmacotherapy is as high as in Omnitram is therefore an opportunity to develop an andquot improved tramadolandquot that is effective in all patients irrespective of their CYP D metabolic status Omnitram successfully completed a Phase b randomized double blind placebo controlled trial that demonstrated Omnitram provided significant analgesia compared to placebo in an experimental pain model in healthy subjects This Fast Track application aims to further the success of the Omnitram program by demonstrating analgesic efficacy in patients suffering from neuropathic pain due to diabetic neuropathy A Cochrane systematic review concluded that tramadol is an effective treatment for neuropathic pain with efficacy similar to that reported for antidepressants and anticonvulsants Omnitram provides the same net pharmacology as tramadol and is therefore predicted to be efficacious in treating neuropathic pain PUBLIC HEALTH RELEVANCE Neuropathic pain is difficult to treat and many patients have pain that is refractory to existing treatments The most commonly studied neuropathic pain subtypes include diabetic neuropathic pain DNP postherpetic neuralgia PHN and HIV related neuropathic pain Collectively these three conditions were estimated to affect over million people across the seven major pharmaceutical markets the United States Japan France Germany Italy Spain and the United Kingdom in However the total affected population is considerably larger owing to the number of additional neuropathic pain conditions such as neuropathic lower back pain cancer related neuropathic pain complex regional pain syndrome and postoperative neuropathic pain Due to the staggering human and economic costs neuropathic pain represents a significant burden to public health This Fast Track proposal would advance a novel mixed mechanism analgesic Omnitram towards clinical evaluation in patients suffering from neuropathic pain