Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EMBEDA- morphine/ naltrexone · 1 trial · 4 indications
| Arm | Type | Description |
|---|---|---|
| Treatment A | PLACEBO_COMPARATOR | Placebo |
| Treatment B | EXPERIMENTAL | EMBEDA 30 mg crushed |
| Treatment C | ACTIVE_COMPARATOR | Morphine Sulfate Controlled Release 30 mg crushed |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Lactose (100 mg) placebo tablets crushed; single dose |
| EMBEDA - morphine sulfate/ naltrexone hydrochloride | DRUG | EMBEDA (morphine sulfate/naltrexone hydrochloride) 30 mg/ 1.2 mg extended release; capsule contents crushed; single dose |
| morphine sulfate CR crushed. | DRUG | Morphine sulfate controlled release 30 mg tablet crushed |
Inclusion Criteria: * Healthy male or female subjects 18 to 55 years of age, inclusive. * Subject is a recreational opioid user who is NOT dependent on opioids based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) criteria and the Naloxone Challenge...
EMBEDA is being studied in the setting of narcotic abuse, with trial activity also listing opioid-related disorders, analgesia, and chronic pain. It is an investigational product and is not described as approved for these uses. Its development work falls within the psychiatry therapeutic area.
EMBEDA is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the sponsor associated with the clinical development program for this morphine and naltrexone combination product.
EMBEDA is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. Because the program remains in early clinical development, EMBEDA is investigational and has not been established as an approved therapy.
EMBEDA has been studied in one completed Phase 1 trial, NCT01595867, titled Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo. The trial enrolled 33 participants, was randomized, double blind, and placebo controlled, and included healthy volunteers aged 18 years and older.
EMBEDA combines morphine, an opioid receptor agonist, with naltrexone, an opioid receptor antagonist. The combination is designed so that the naltrexone component interacts with opioid receptors, which is the basis for studying the product in abuse potential assessments.