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news.Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for Nucynta ER (tapentadol) extended-release tablets.
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The drug is an oral analgesic, for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults.
The sNDA submission occurred on the back of Phase 3 double-blind, randomized, active-and placebo-controlled studies which evaluated the efficacy and safety of Nucynta ER for the management of neuropathic pain associated with DPN in adults.
The data demonstrated that the drug reduces diabetic peripheral neuropathic pain compared to placebo.