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 20h 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) for moderate to severe chronic pain requiring continuous opioid therapy. The naltrexone component is designed to reduce opioid-induced constipation while maintaining analgesic efficacy through a unique sequestered-core formulation. This dual-mechanism approach addresses a major tolerability barrier in long-term opioid therapy.
Peak3.3 years to LOE
EMBEDA is at peak lifecycle with high competitive pressure (8/10), indicating a mature franchise requiring defensive commercial execution and team focus on market retention against generic and alternative therapies.
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.