EMBEDA
Peakmorphine sulfate; naltrexone hydrochloride
NDAORALCAPSULE, EXTENDED RELEASEPriority Review
Approved
Aug 2009
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
6
Data completeness
5/8 — Partial
Priority Review
EMBEDA (morphine sulfate; naltrexone hydrochloride) is ] . Approved for moderate to severe pain, around-the-clock opioid analgesic is needed for an extended period of time. First approved in 2009.
Drug data last refreshed 14h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EMBEDA is an extended-release oral capsule combining morphine sulfate (mu-opioid agonist) with naltrexone hydrochloride (mu-opioid antagonist) designed to provide around-the-clock analgesia while reducing opioid-induced constipation and abuse potential. It is indicated for moderate to severe pain requiring continuous opioid therapy for extended periods. The naltrexone component is released in the GI tract to block local opioid effects on smooth muscle, while morphine is absorbed systemically for analgesia.
Peak3.1 years to LOE
Product is at peak commercial maturity with 15+ years post-launch; team focus likely shifting to maintaining market position against generic/biosimilar erosion and defensive indications.
Mechanism of Action
] . Effects on the Gastrointestinal Tract and Other Smooth Muscle Gastric, biliary, and pancreatic secretions are decreased by morphine. Morphine causes a reduction in motility associated with an increase in tone in the antrum of the stomach and duodenum. Digestion of food in the small intestine is…
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.