NDAORALTABLET, EXTENDED RELEASE
Approved
Aug 2011
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
2
Data completeness
6/8 — Strong
NUCYNTA ER (tapentadol hydrochloride) by Humanwell Pharmaceutical is centrally-acting synthetic analgesic. Approved for chronic pain, back pain, osteoarthritis. First approved in 2011.
Drug data last refreshed 23h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NUCYNTA ER is an extended-release oral tablet formulation of tapentadol hydrochloride, a centrally-acting synthetic opioid analgesic approved in 2011. It works through dual mechanisms: mu-opioid receptor agonism and norepinephrine reuptake inhibition, with analgesia derived from both pathways. The product is indicated for acute pain severe enough to require opioid therapy when alternative treatments are inadequate in adults and pediatric patients weighing at least 40 kg. NUCYNTA ER currently occupies a peak lifecycle position within the competitive opioid analgesic market.
$0.1BPart D
2.9 years to LOEMechanism of Action
centrally-acting synthetic analgesic. The exact mechanism of action is unknown. Although the clinical relevance is unclear, preclinical studies have shown that tapentadol is a mu-opioid receptor (MOR) agonist and a norepinephrine reuptake inhibitor (NRI). Analgesia in animal models is derived from…
Indications (3)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.