MEDICAL NEED Sample Clauses

MEDICAL NEED. Pharmacologic treatments for diabetic neuropathy have been shown to be efficacious for diabetic neuropathic pain, and not for other aspects of diabetic neuropathy. Multiple drugs including tricyclic antidepressants (eg, amitriptyline), selective serotonin-norepinephrine reuptake inhibitors (SSNRIs) (eg, duloxetine), anticonvulsants (eg, gabapentin, pregabalin), and opiates (eg, oxycodone, tramadol) are used, but only pregabalin (Lyrica®), duloxetine (Cymbalta®), and the opioid tapentadol-ER (Nucynta) are approved by the US Food and Drug Administration (FDA) for the treatment of diabetic neuropathic pain. Unfortunately, many patients’ symptoms fail to respond to these drugs, and among responders, few patients experience complete symptom control and remission of pain. Additionally, the available medications are associated with unwanted effects, and many patients tolerate them poorly. There thus remains a large, unmet medical need for new treatments that are efficacious and well-tolerated in patients with diabetic neuropathic pain, as well as more broadly for the treatment of diabetic neuropathy.