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 4d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EMBEDA is an extended-release oral capsule combining morphine sulfate (a mu-opioid agonist) with naltrexone hydrochloride (a mu-opioid antagonist) for moderate to severe pain requiring around-the-clock opioid therapy. The naltrexone component is designed to reduce opioid-induced gastrointestinal side effects, particularly constipation, by antagonizing mu-opioid receptors in the gut while maintaining systemic analgesia. This dual-mechanism approach addresses a major tolerability barrier in chronic opioid therapy.
Peak3.5 years to LOE
Product is in peak commercial maturity with 15 years post-launch history; competitive pressure score of 8/10 indicates mature market environment requiring defensive positioning and efficiency.
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.