EMBEDA

Peak

morphine sulfate; naltrexone hydrochloride

NDAORALCAPSULE, EXTENDED RELEASEPriority Review
Approved
Aug 2009
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
5

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…

Clinical Trials (5)

NCT02101554Phase 4Terminated

Safety and Pharmacokinetic Study of EMBEDA in Children Ages 7-17 With Pain

Started Apr 2015
19 enrolled
Moderate-severe Pain
NCT01595867Phase 1Completed

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
NCT01179191Phase 4Terminated

Conversion to Embeda With Rescue Trial

Started Aug 2010
684 enrolled
Chronic DiseasePain
NCT00415597Phase 3Completed

Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain

Started Dec 2006
467 enrolled
Pain
NCT00420992Phase 3Completed

A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee

Started Dec 2006
547 enrolled
OsteoarthritisChronic Pain

Loss of Exclusivity

LOE Date
Nov 7, 2029
44 months away
Patent Expiry
Nov 7, 2029

Patent Records (5)

Patent #ExpiryTypeUse Code
8158156
Jun 19, 2027
U-1510
7682634
Jun 19, 2027
Product
8846104
Jun 19, 2027
Product
8877247
Jun 19, 2027
Product
7682633
Jun 19, 2027
U-1510