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New Study Shows Tapentadol Extended Release (ER) May Significantly Reduce Average Pain Intensity for Diabetic Patients Suffering From Painful Peripheral Neuropathy
Date:1/28/2011

nical resistance, such as to crushing or chewing. The NDA filing is part of the ongoing commitment of J&JPRD and PriCara® to bring new and innovative products to patients and physicians for the treatment and management of pain.

In October 2010, J&JPRD announced it had received a Complete Response letter from the FDA regarding its NDA for tapentadol extended release tablets [http://www.jnj.com/connect/news/product/FDA-Issues-Complete-Response-Letter-to-Johnson-and-Johnson-Pharmaceutical-Research-Development-Regarding-New-Drug-Application-for-Tapentadol-Extended-Release]. J&JPRD is working to address the FDA's requests as quickly as possible.  No new clinical studies were requested by the agency.

IMPORTANT SAFETY INFORMATION FOR NUCYNTA® (tapentadol immediate release) Contraindications

Like other drugs with mu-opioid agonist activity, NUCYNTA® is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma or hypercapnia in unmonitored settings or in the absence of resuscitative equipment.  NUCYNTA® is contraindicated in patients who have or are suspected to have paralytic ileus.  NUCYNTA® is also contraindicated in patients currently using or within 14 days of using monoamine oxidase inhibitors (MAOIs) due to potential additive effects on norepinephrine levels, which may result in adverse cardiovascular events.

Warnings & Precautions

Respiratory depression is the primary risk of mu-opioid agonists. Respiratory depression occurs more frequently in elderly or debilitated patients and in those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction, in whom even moderate therapeutic doses
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SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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