NDAORALTABLET, EXTENDED RELEASEPriority Review
Approved
Mar 2014
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
4/8 — Partial
Priority Review
XARTEMIS XR (acetaminophen; oxycodone hydrochloride) by Johnson & Johnson is mechanism of action oxycodone is a full opioid agonist with relative selectivity for the mu-opioid receptor, although it can interact with other opioid receptors at higher doses. Approved for pain severe enough to require an opioid analgesic, for which alternative treatments are inadequate. First approved in 2014.
Drug data last refreshed 3d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XARTEMIS XR is an extended-release oral tablet combining oxycodone (a full mu-opioid agonist) with acetaminophen for moderate-to-severe pain management. It is indicated for patients with pain severe enough to require opioid analgesia when alternative treatments are inadequate. Oxycodone provides analgesia via central CNS opioid receptors with no ceiling effect, while acetaminophen's precise mechanism remains unclear but involves central analgesic action.
Peak6.0 years to LOE
Product is at peak commercial stage with established market presence; brand teams focus on market share defense and maximizing existing indications.
Mechanism of Action
Mechanism of Action Oxycodone is a full opioid agonist with relative selectivity for the mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Like all full opioid agonists, there is no ceiling effect…
Indications (2)
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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.