NDAINJECTIONINJECTABLEPriority Review
Approved
Aug 1978
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
STADOL PRESERVATIVE FREE (butorphanol tartrate) by Bristol Myers Squibb is mechanism of action butorphanol is a partial opioid agonist at the mu opioid receptor and a full agonist at the kappa opioid receptor. Approved for pain severe enough to require an opioid analgesic, for which alternative treatments are inadequate. First approved in 1978.
Drug data last refreshed 3d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
STADOL PRESERVATIVE FREE is an injectable butorphanol tartrate, a partial mu-opioid agonist and full kappa-opioid agonist indicated for severe pain requiring opioid analgesia when alternative treatments are inadequate. The drug works by binding to opioid receptors in the central nervous system to produce analgesia, with clinical dosing titrated to balance pain relief against respiratory and CNS depression.
LOE Approaching
Product is in late-stage lifecycle with declining competitive position; brand team focus is likely defensive, prioritizing retention and cost management rather than growth initiatives.
Mechanism of Action
Mechanism of Action Butorphanol is a partial opioid agonist at the mu opioid receptor and a full agonist at the kappa opioid receptor. The principal therapeutic action of butorphanol is analgesia. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions,…
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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.