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Chronic Pain Drug Nucynta ER Granted FDA Approval for Management Of Diabetic Peripheral Neuropathy

On August 29, J&J’s chronic pain drug Nucynta ER (tapentadol) was granted FDA approval for the management of the pain associated with diabetic peripheral neuropathy (DPN). Diabetic neuropathy is one of the most common complications of diabetes, affecting about half of all people with diabetes at some point in their lifetimes. Peripheral neuropathy, which primarily affects the legs and feet, is one of the most common forms of this condition. Improved blood glucose control can slow down and sometimes even reverse the damage to nerves, but medications and devices are often still needed to treat the pain and numbness of neuropathy. Nucynta ER is the third drug to gain FDA approval to treat DPN, following Eli Lilly’s antidepressant Cymbalta (duloxetine) and Pfizer’s anticonvulsant Lyrica (pregabalin). Last month also saw the approval of NeuroMetrix’s pain management device Sensus for DPN (see new now next in diaTribe #46).

We recently had a chance to talk with Dr. Keith Candiotti, a professor at the University of Miami School of Medicine and consultant to J&J for Nucynta ER. Notably, he suggested that Nucynta ER could be particularly useful for people who are experiencing especially intense pain from DPN, or an exacerbation of their existing pain. This is because Nucynta ER works by directly increasing the activity of the brain’s pain relief, known as the opioid receptors. This also means Nucynta ER treats DPN in a fundamentally different way than Cymbalta and Lyrica. This is great news because DPN affects so many different aspects of the brain and body, which makes it notoriously complicated to treat, and there’s no guarantee a drug therapy that is successful for one person will work for others. Nucynta ER is specifically approved to treat the painful symptons of DPN when a continuous, round-the-clock opioid analgesic is required. Adding more treatment options for DPN is always needed, and we’re hopeful Nucynta ER can provide some relief for those who have not had success with Cymbalta or Lyrica. –AW

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