FDA Approves New Neuropathy Pain Drug

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The US Food and Drug Administration has approved US sales of NUCYNTA® ER (tapentadol), a twice-daily extended-release oral analgesic for the treatment of pain from diabetic peripheral neuropathy. The drug, produced by New Jersey-based Janssen Pharmaceuticals, Inc., provides around-the-clock management for moderate to severe chronic neuropathic pain. Janssen says that it is currently the only opioid on the US market that has been approved for treating the condition.

An estimated 8 million people in the United States suffer from diabetic peripheral neuropathy, a condition in which high blood sugar inflames and damages nerves in the extremities—arms, hands, legs, feet, and toes. The most common symptoms are numbness, burning, tingling, or tickling sensations in the affected areas. However, those symptoms often give way to extreme pain.

Treatment for diabetic neuropathy pain can involve the use of several drug agents, including anti-seizure medications, antidepressants, lidocaine topical patches, and opioids used to treat pain in general. All drugs used to treat the condition have side effects, the most common being dizziness and drowsiness. Janssen states that most common adverse reactions reported by patients treated with NUCYNTA ER were nausea, constipation, vomiting, dizziness, headache, and sleepiness. 

Because the active ingredient in NUCYNTA® ER, tapentadol, is classified as a controlled substance, it will be available by prescription only. The twice-daily pill will come in strengths of 50, 100, 150, 200, and 250 mg.

Janssen has listed certain cautions about the drug, including the potential for abuse because of the drug’s opioid nature, the possibility of life-threatening respiratory depression if the drug is ingested improperly (such as crushing the pill so that its extended-release capability is destroyed), and potential bad interactions with alcohol.

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