Issue 47 September 2012
7. Drug and Device updates


FDA Approves Tapentadol ER for Diabetic Neuropathy

The US Food and Drug Administration (FDA) has approved Tapentadol extended-release (ER) (Nucynta, Janssen Pharmaceuticals, Inc) for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults for whom a continuous opioid analgesic is required over an extended time.It is the first opioid to receive this indication, the company notes in a statement today.

Tapentadol ER is already approved for the treatment of moderate to severe chronic pain in adults requiring a continuous opioid analgesic for an extended period. It is a centrally acting synthetic analgesic, although the exact mechanism of action is unknown, the release states.

"Although the clinical relevance is unclear," the company notes, preclinical studies showed that it acts as both a mu-opioid receptor and a norepinephrine reuptake inhibitor. Currently, 2 drugs (duloxetine, a selective serotonin and norepinephrine reuptake inhibitor, and pregabalin, an anticonvulsant) are approved in the United States for the management of pain associated with DPN.

New biosensor created

Researchers have created a new type of biosensor that can detect even minute concentrations of glucose in four different human serums: saliva, tears and urine as well as blood. The nana technology based sensor uses nanosheets made of graphene, platinum nanoparticles and an enzyme (glucose oxidase) that converts glucose to peroxide, which generates a signal on an electrode. The biosensor might one day be a welcome relief to diabetes patients who have to regularly prick their fingers to test their sugar levels.

One major benefit is that this nanostructured bio sensor implementation can be done without resorting to complex and expensive fabrication procedures involving lithography, chemical processing, etching etc. “The good thing about these petal shaped sensors is that they can be grown on just about any surface, and we don't need to use any of these steps, so it could be ideal for commercialization. said Purdue doctoral student Anurag Kumar who was a lead in the project.

Another advantage is that the sensor is able to distinguish between glucose and signals from other compounds that often cause interference in sensors: uric acid, ascorbic acid and acetaminophen, which are commonly found in the blood. Unlike glucose, those compounds are said to be electro active, which means they generate an electrical signal without the presence of an enzyme.

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