NDAINJECTIONINJECTABLE
Approved
Jul 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
3/8 — Basic
MORPHINE SULFATE (morphine sulfate) by Pfizer is mu-opioid receptor, although it can bind to other opioid receptors at higher doses. First approved in 1996.
Drug data last refreshed 1h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Morphine Sulfate is a full mu-opioid receptor agonist indicated for moderate to severe pain across acute, chronic, cancer, and postoperative settings, as well as neonatal abstinence syndrome and opioid use disorder. It works by binding to opioid receptors in the brain and spinal cord to produce analgesia without a ceiling effect. Dosing is titrated to effect and limited by adverse reactions including respiratory and CNS depression.
LOE Approaching
Product approaching loss of exclusivity with declining commercial momentum, suggesting smaller brand team and focus on transition planning rather than growth initiatives.
Mechanism of Action
mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of morphine is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with morphine. Clinically, dosage is titrated to provide adequate analgesia and may…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo
Started Aug 2010
33 enrolled
Narcotic AbuseOpioid-related DisordersAnalgesia+1 more
Study to Determine the Bioavailability, Pharmacodynamic Effects, and Safety of Whole and Crushed ALO-01 Compared to Morphine Sulfate Immediate Release (MSIR)
Started Mar 2007
32 enrolled
Healthy
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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.