The U.S. Food and Drug Administration has approved the use of the first opioid painkiller for the treatment of neuropathic pain caused by diabetic peripheral neuropathy. Nucynta, which is made by Janssen Pharmaceuticals, is already approved for management of moderate to severe chronic pain in adults.
The expanded approval from the FDA allows Janssen, a division of Johnson & Johnson (NYSE: JNJ), to market Nucynta for pain relief to nearly 8 million Americans who have diabetic peripheral neuropathy (DPN). The expanded use comes at a time when the FDA is being petitioned by some physicians and public health officials to reduce the approved uses of opioids, not expand them.
Nearly 26 million people in the United States have diabetes and about half have some form of neuropathy, according to the American Diabetes Association. DPN causes pain or loss of feeling in the toes, feet, legs, hands and arms. It may also include a persistent burning, tingling or prickling sensation.
“Pain from DPN can be difficult to manage, leaving some patients and healthcare professionals looking for alternative treatments,” said Keith A. Candiotti, MD, who is a professor at the University of Miami School of Medicine and a paid consultant to Janssen Pharmaceuticals. “Nucynta is a different option than currently approved medications for the management of painful DPN and may be an important new choice for these patients.”
According to Janssen, Nucynta reduced pain significantly in patients enrolled in two Phase III clinical studies. The most common side effects were nausea, constipation, vomiting, dizziness, headache and somnolence.
Nucynta is the brand name of tapentadol, a strong opioid medicine classified as a Schedule II drug under the Controlled Substances Act. It is available only by prescription for management of moderate to severe chronic pain
Last month dozens of doctors, researchers and public health officials petitioned the FDA to limit the dose and duration of opioid prescriptions, and to limit the approved use of opioids to severe non-cancer pain only. The petitioners, many of them associated with Physicians for Responsible Opioid Prescribing (PROP), cited an epidemic of prescription drug overdoses – many of them caused by opioid painkillers.
Since the petition was submitted, the FDA has now expanded the approved use of three opioids. In addition to approving the use of Nucynta to treat DPN, the agency doubled the approved dosage of Exalgo, an opioid painkiller used to treat moderate to severe pain. The FDA also approved stronger 4 mg and 12 mg doses of Suboxone, which is used to treat opioid dependence.