WASHINGTON -- The FDA has approved the first opioid painkiller for neuropathic pain associated with diabetic peripheral neuropathy, according to the drug maker.
Tapentadol (Nucynta ER) is an extended-release formulation of the oral analgesic. The twice-daily drug is targeted to adult diabetic patients with neuropathic pain who require continuous, around-the-clock opioid analgesic treatment, said Janssen Pharmaceuticals in a statement.
The drug was initially approved in 2008 as a treatment for moderate to severe acute pain management in adult patients with severe acute pain.
The extended-release formulation of tapentadol was indicated to include twice-daily treatment for patients with severe chronic pain who needed continuous treatment.
Safety and efficacy for the new indication were established in two randomized-withdrawal phase III trials. Among patients who had experienced at least one point reduction in pain after 3 weeks of drug treatment, those treated with tapentadol over 12 weeks experienced significantly better pain control than those switched to placebo.
Adverse events during trials included nausea, constipation, dizziness, headache, somnolence, vomiting, and headache.
Tapentadol is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma or hypercarbia in an unmonitored setting, hypersensitivity, gastrointestinal obstruction, and in patients taking monoamine oxidase inhibitors.
Patients taking tapentadol may be at risk for life-threatening respiratory depression, even if taken as indicated.
Patients taking serotonergic drugs with tapentadol are at risk for life-threatening serotonin syndrome.
The drug should not be taken accidentally or in excess of prescribed amounts due to risk of potentially fatal overdose, particularly if the drug is taken with alcohol.
As an opioid agonist, the drug has the potential for abuse or addiction.
Those discontinuing use of the drug should taper use, according to the company.
Janssen Pharmaceuticals is based in Raritan, N.J.
Cole Petrochko
Staff Writer
Cole Petrochko started his journalism career at MedPage Today in 2009, after graduating from New York University with B.A.s in Journalism and Psychology. When not writing for MedPage Today, he blogs about nerd culture, designs websites, and buys and sells collectible card game cards. He is based out of MedPage Today's Little Falls, N.J. Headquarters.
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