Nucynta (tapentadol; Collegium Pharmaceutical) first gained US Food and Drug Administration (FDA) approval in November 2008 as an immediate-release formulation, for the relief of acute pain, and was the first novel opioid to be launched for pain in more than 25 years. Upon approval, tapentadol was listed as a Schedule II controlled substance by the US Drug Enforcement Administration, and is treated in a similar fashion within the EU. The twice-daily extended-release formulation Nucynta ER was subsequently approved for moderate to severe chronic pain in August 2011, and for neuropathic pain associated with diabetic peripheral neuropathy in August 2012.
Nucynta ER is currently marketed in the US by Collegium Pharmaceutical under license from Depomed. Depomed had acquired rights to the drug from its original developers, Grünenthal and Johnson & Johnson.
4 Drug Overview
5 Product Profiles
5 Nucynta ER : Neuropathic pain
LIST OF FIGURES
9 Figure 1: Nucynta ER for neuropathic pain – SWOT analysis
10 Figure 2: Datamonitor Healthcare’s drug assessment summary of Nucynta ER for neuropathic pain
11 Figure 3: Datamonitor Healthcare’s drug assessment summary of Nucynta ER for neuropathic pain
13 Figure 4: Nucynta ER sales for neuropathic pain across the US, Japan, and major EU markets, by country, 2017–26
LIST OF TABLES
5 Table 1: Nucynta ER drug profile
7 Table 2: Nucynta ER Phase III data in diabetic neuropathy
14 Table 3: Nucynta ER sales for neuropathic pain across the US, Japan, and major EU markets, by country ($m), 2017–26
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