FDA Approves NeuroMetrix’s Sensus to Treat Painful Diabetic Neuropathy

Over the course of their lifetimes, roughly half of all people with diabetes develop diabetic neuropathy, which affects the nerves and can cause feelings of numbness and pain, particularly in the extremities. Tight blood glucose control may slow down and possibly reverse underlying nerve damage for some individuals, but not for all. Currently there are two primary medications available to treat the pain and numbness of diabetic neuropathy: Eli Lilly’s treatment for pain (also used for depression), Cymbalta (duloxetine), Pfizer’s treatment for epilepsy, Lyrica (pregabalin), and J&J’s chronic pain medication Nucynta ER (tapentadol), which was approved just this past week to treat neuropathy (we will have more on this late-breaking story in the next issue). In early August, the number of treatment options expanded when NeuroMetrix received FDA clearance for its Sensus Pain Management device for the treatment of chronic intractable pain, including painful diabetic neuropathy (PDN). The new device treats PDN by noninvasively transmitting painless, low frequency electric impulses through the body, a process known as transcutaneous electrical nerve stimulation (TENS). The device is worn on the calf, works at the press of a single button, and is equipped with a rechargeable battery that should last about two weeks based on the recommended once-daily, hour-long treatment sessions. NeuroMetrix intends to launch Sensus at the end of 2012. The company has not released information on how Sensus will be priced, but we hope that insurance companies and Medicare and Medicaid will reimburse the device. Considering how painful neuropathy can be, we’re very keen for more alternatives to treat this complication, and we look forward to Sensus becoming available as a potential alternative for patients. –AW