Powerful Opioid Approved for Diabetic Peripheral Neuropathy
By Ross Bonander, Thu, August 30, 2012
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. This was approved back in August of 2011 as a new formulation only. This most recent approval is for diabetic peripheral neuropathy.
Classification
Nucynta ER has been classified as a Schedule II drug, meaning that it is much more tightly controlled by the DEA, and more difficult to obtain by patients from doctors, because it is considered to be 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 contraindicated in 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, in patients don't even need any serious lung problems and they can still be at risk for life-threatening respiratory depression--even if they take Nucynta ER as directed.
Benefits
Because 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 now will be covered by Medicare, and 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.
http://www.informationaboutdiabetes.com/lifestyle/treatment/medication/powerful-opioid-approved-for-diabetic-peripheral-neuropathy
nice
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