Powerful Opioid Approved for Diabetic Peripheral Neuropathy
The US Food & Drug Administration has approved a powerful opioid painkiller for the relief of neuropathic pain associated with diabetic peripheral neuropathy.
The drug is tapentadol, marketed under the brand name Nucynta. It was first FDA approved in oral tablet form back in 2008 for moderate to severe acute pain management.
The formulation of the drug now approved for diabetic peripheral neuropathy is Nucynta ER, an extended-release oral tablet. It was approved back in August of 2011 as a new formulation only. The most recent approval is for diabetic peripheral neuropathy.
Nucynta ER is classified as a Schedule II drug, meaning that it is tightly controlled by the DEA and difficult to obtain by patients from doctors because it is considered highly habit-forming. Similar schedule II opioids include Percocet, Oxycontin, Morphine, and Dilaudid, to name just a few (Vicodin and codeine are schedule III).
Nucynta ER does not come without a short-list of warnings, typical of opioids in its class. For example, according to the FDA Medication Guide for Nucynta ER (opens as PDF) the drug is not recommended for patients who have "significant respiratory depression, acute or severe bronchial asthma or hypercarbia in an unmonitored setting, hypersensitivity, gastrointestinal obstruction, and in patients taking monoamine oxidase inhibitors."
In fact, patients without serious lung problems can still be at risk for life-threatening respiratory depression--even if they take Nucynta ER as directed.
The pain of diabetic associated peripheral neuropathy can be very difficult to manage. Nucynta ER--which looks to be a twice-daily medication--will provide long-lasting pain relief to this patient population.
Its FDA approval for this indication, however, means that the drug will be covered by Medicare. Considering the patent on Nucynta will remain in place for several more years, meaning no cheaper generic is in sight anytime soon, some private insurance companies should help cover its cost as well.