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FDA has Approved Tapentadol (Nucynta): an Extended-Release Oral Opioid

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FDA has Approved Tapentadol (Nucynta): an Extended-Release Oral Opioid

Post  Admin on Sat Aug 27, 2011 5:46 pm

FDA has approved Tapentadol (Nucynta), an extended-release oral opioid, to treat severe chronic pain

Aug 26, 2011.
Nucynta ER (tapentadol extended release) has been approved by the U.S. Food and Drug Administration to treat moderate-to-severe chronic pain in adults, maker Janssen Pharmaceuticals said. The original formulation of Nucynta was approved by the FDA in 2008.

The approval is based on a randomized, double-blind, controlled phase III study that tested tapentadol as a treatment for moderate to severe low-back pain and diabetic peripheral neuropathy.

Tapentadol was also well-tolerated, the company said. Opioids can cause a number of side effects, including constipation, that may cause patients to discontinue their use.
A 2010 phase III study comparing the drug to oxycodone in patients with painful knee osteoarthritis found that tapentadol provided effective pain relief with fewer of the gastrointestinal side effects seen with oxycodone.

The approval also comes with a Risk Evaluation and Mitigation Strategy (REMS), similar those approved for other opioids, meant to educate prescribers about the potential of abuse, misuse, overdose, and addiction with extended-release tapentadol.

The CDC estimates that 42 million Americans over the age of 20 suffer from chronic pain.



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