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 1h ago · AI intelligence enriched 1h 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 by the FDA in January 2017. It is indicated for the management of pain severe enough to require around-the-clock opioid treatment, working by binding to opioid receptors in the central nervous system to provide analgesia without a ceiling effect. The principal action is pain relief, with dosing titrated to individual patient tolerance and adverse reaction profile.
Peak6.8 years to LOE
Product is in peak commercial maturity with patent protection extending to 2033, suggesting stable team size and established commercial infrastructure for field and medical roles.
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
Worked on ARYMO ER at Pfizer? Share your interview experience or compensation data (+7 days Pro)
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.