{"id":30139,"date":"2012-08-30T02:04:01","date_gmt":"2012-08-30T06:04:01","guid":{"rendered":"http:\/\/asweetlife.org\/?post_type=news&p=30139"},"modified":"2015-12-29T09:18:04","modified_gmt":"2015-12-29T14:18:04","slug":"fda-approves-janssens-nucynta-er-for-diabetic-peripheral-neuropathy-pain","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=30139","title":{"rendered":"FDA Approves Janssen’s NUCYNTA ER for Diabetic Peripheral Neuropathy Pain"},"content":{"rendered":"
\"\"<\/a>The U.S. FDA\u00a0has approved the supplemental New Drug Application (sNDA), submitted by\u00a0Janssen Pharmaceuticals,\u00a0for NUCYNTA\u00a0ER (tapentadol) extended-release tablets. NUCYNTA ER is an oral analgesic taken twice daily, for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.\u00a0<\/div>\n
\n

NUCYNTA\u00ae<\/sup>\u00a0ER is the first and only opioid approved by the FDA for neuropathic pain associated with DPN. In addition to this new indication, NUCYNTA\u00a0ER is currently approved for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.<\/span><\/p>\n

NUCYNTA\u00a0<\/sup>ER is a centrally-acting synthetic analgesic. The exact mechanism of action is unknown. Although the clinical relevance is unclear, preclinical studies have shown that NUCYNTA\u00a0ER acts as both a mu-opioid receptor and a norepinephrine reuptake inhibitor.<\/span><\/p>\n

Data from two randomized-withdrawal, placebo-controlled Phase 3 trials showed, among patients who had at least a one-point reduction in pain intensity during three weeks of treatment with NUCYNTA\u00a0ER, those who continued on the same dose of NUCYNTA\u00a0ER that was titrated to balance individual tolerability and efficacy (100-250mg twice daily) for an additional 12 weeks experienced significantly better pain control compared to those who switched to placebo. The findings also demonstrated that NUCYNTA\u00a0<\/sup>ER was generally well tolerated. The most common (?10% of NUCYNTA\u00a0ER treated patients) adverse reactions were nausea, constipation, vomiting, dizziness, headache and somnolence.<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

The U.S. FDA has approved the supplemental New Drug Application (sNDA), submitted by Janssen Pharmaceuticals, for NUCYNTA ER (tapentadol) extended-release tablets. NUCYNTA ER is an oral analgesic taken twice daily, for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. <\/p>\n","protected":false},"author":131,"featured_media":30142,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[1542],"tags":[1568],"yoast_head":"\nFDA Approves Janssen's NUCYNTA ER for Diabetic Peripheral Neuropathy Pain<\/title>\n<meta name=\"description\" content=\"The 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