Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain

Neuropathic pain state is usually refractory to most analgesic regimens, and requires
polypharmacy for symptomatic relief. Current treatment options for neuropathic pain include
both oral and topical medications. Most commonly prescribed oral treatments include
antidepressants (e.g., amitriptyline, desipramine, and duloxetine), antiepileptics (e.g.,
gabapentin, pregabalin) and opiates such as tramadol and morphine. Current topical
treatments include lidocaine patch and Capsaicin Patch. Many patients have inadequate pain
relief in spite of these treatment options.

Currently there are no treatments available for treatment of neuropathy itself other than
treating the underlying cause and addressing the symptomatic relief for pain. Current drug
therapies for neuropathic pain provide inadequate pain relief and undesirable side effects
including sedation and cognitive dysfunction. It is not uncommon to use a combination of
agents for the treatment of neuropathic pain to minimize the side effects. Although treating
the mild to moderate pain may be relatively easy, it is very challenging to the severe forms
of neuropathic pain. Although the use of Opiates for neuropathic pain is well accepted,
remains controversial because of the potential for abuse and diversion