NDAORALTABLETPriority Review
Approved
Jan 1953
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
LEVO-DROMORAN (levorphanol tartrate) by Bausch + Lomb is clinical pharmacology mechanism of action levorphanol is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to 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 1953.
Drug data last refreshed 8h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LEVO-DROMORAN (levorphanol tartrate) is a full mu-opioid receptor agonist oral tablet approved in 1953 for severe pain inadequately managed by alternative treatments. It works by binding to opioid receptors in the central nervous system to produce analgesia without a ceiling effect, though dosing is limited by respiratory and CNS depression.
LOE Approaching
This legacy opioid faces imminent loss of exclusivity with minimal commercial investment and declining market presence, indicating potential downsizing or divestment activity by Bausch + Lomb.
Mechanism of Action
CLINICAL PHARMACOLOGY Mechanism of Action Levorphanol is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of levorphanol is analgesia. Like all full opioid agonists, there…
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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.