NDAORALTABLET, EXTENDED RELEASE
Approved
Jan 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
2
Data completeness
4/8 — Partial
ARYMO ER (morphine sulfate) by Pfizer is mu-opioid receptor, although it can bind to other opioid receptors at higher doses. First approved in 2017.
Drug data last refreshed 5h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ARYMO ER is an extended-release oral tablet formulation of morphine sulfate, a full mu-opioid receptor agonist approved in 2017. It is indicated for moderate to severe pain management in opioid-tolerant patients, working through CNS mu-opioid receptor binding to provide analgesia without a ceiling effect. Dosing is titrated individually based on analgesic efficacy and tolerability.
Peak7.0 years to LOE
Product is in peak commercial phase with stable market positioning; brand teams focus on maintaining market share in the competitive extended-release morphine segment.
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.