NDAORALTABLET
Approved
Nov 2008
Lifecycle
LOE Approaching
Competitive Pressure
35/100
Clinical Trials
3
Data completeness
5/8 — Partial
NUCYNTA (tapentadol hydrochloride) by Humanwell Pharmaceutical is centrally-acting synthetic analgesic. Approved for pain, low back pain, osteoarthritis. First approved in 2008.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NUCYNTA (tapentadol hydrochloride) is an oral tablet centrally-acting synthetic analgesic approved in November 2008 for acute pain severe enough to require an opioid analgesic when alternative treatments are inadequate in adults and older patients weighing at least 40 kg. The drug operates through a dual mechanism: mu-opioid receptor (MOR) agonism and norepinephrine reuptake inhibition (NRI), with analgesia derived from both properties in preclinical models. It represents a distinct pharmacological approach within the opioid analgesic class, combining opioid and norepinephrine-targeting mechanisms.
$0.1BPart D
2mo 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.