New Drug for Diabetic Pain

Nucynta ER for diabetic peripheral neuropathy approved by FDA

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) People with diabetes are at risk for many other health problems, including a condition that causes pain or numbness in the feet, legs, hands and arms. Now, there's a new painkiller for patients with this condition.

The FDA has approved Nucynta ER (tapentadol) for managing pain in patients with diabetic peripheral neuropathy - a nerve problem in diabetes patients that can cause pain and burning, tingling or prickling feelings.

Nucynta ER is the first and only opioid (type of pain drug) approved by the FDA to treat pain in patients with diabetic peripheral neuropathy.

"Ask your doctor about drug options for managing pain."

Of the nearly 26 million Americans with diabetes, about 60 to 70 percent have some type of neuropathy. Diabetic peripheral neuropathy is the most common type of neuropathy.

Because of the complex nature of the condition, patients with diabetic peripheral neuropathy often need more than one drug treatment.

"Pain from diabetic peripheral neuropathy can be difficult to manage, leaving some patients and healthcare professionals looking for alternative treatments," said Keith A. Candiotti, MD, of the University of Miami School of Medicine, in a press release from Johnson & Johnson.

"Nucynta ER is a different option than currently approved medications for the management of painful diabetic peripheral neuropathy and may be an important new choice for these patients," said Dr. Candiotti.

Nucynta ER is manufactured by Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson.

Two recent Phase 3 trials showed that Nucynta ER controlled pain and was relatively safe.

Findings showed that patients who had less pain after three weeks of Nucynta ER treatment and continued taking Nucynta ER for another 12 weeks had much better pain control than patients who switched to placebo after the first three weeks.

The most common side effects of Nucynta ER were nausea, constipation, vomiting, dizziness, headache and drowsiness.

"The approval of Nucynta ER for diabetic peripheral neuropathy pain represents the ongoing commitment of Janssen to bring new and innovative products to patients and physicians for the management of pain," said Paul Chang, Vice President of Medical Affairs at Janssen Pharmaceuticals, Inc.

"It is exciting that our in-depth experience in pain management allows us to continue to provide patients with effective options to treat their pain," Chang said.

Be sure to talk to your doctor before starting any medication.

Reviewed by: 
Review Date: 
August 30, 2012
Last Updated:
September 2, 2012