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 3d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LEVO-DROMORAN (levorphanol tartrate) is an oral full mu-opioid agonist indicated for severe pain requiring opioid treatment when alternatives are inadequate. It works by binding to mu-opioid receptors in the brain and spinal cord, producing analgesia without a ceiling effect, though clinical dosing is limited by adverse effects including respiratory and CNS depression.
LOE Approaching
Product approaching loss of exclusivity with minimal recent commercial data; team likely focused on cost management and retention rather than growth expansion.
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.