Drugs / EMBEDA
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | EMBEDA | — | 2009-08-13 | fda.gov ↗ |
Trials 2 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01595867 | Aug 2010 → Jan 2011 | chronic pain syndrome, opioid abuse | Pfizer | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01100437 | Apr 2010 → Mar 2011 | chronic pain syndrome | Pfizer | Terminated | No outcome recorded |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | EMBEDA | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01595867 ↗ |
| Known as | morphine sulfate/naltrexone hydrochloride | “EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush” NCT01100437 ↗ |
| Route | Oral | “EMBEDA (morphine sulfate plus naltrexone hydrochloride ER) capsules crushed and mixed in solution and administered orally” NCT01100437 ↗ |