Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EMBEDA · 1 trial · 1 indication
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours (hrs) (0-2).
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). Emax = Maximum observed score.
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| MS Contin (morphine sulfate, controlled release) | ACTIVE_COMPARATOR | - |
| EMBEDA (morphine sulfate / naltrexone hydrochloride) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Single-dose, 2 x microcrystalline cellulose (weighed to equal weights of average tablet/capsule of active comparator) mixed with 150 ml artificially sweetened, non-carbonated beverage |
| MS Contin (morphine sulfate, controlled release) | DRUG | Single-dose, 2 x 60 mg morphine sulfate whole tablets manually crushed and mixed with 150 ml artificially sweetened, non-carbonated beverage |
| EMBEDA (morphine sulfate / naltrexone hydrochloride) | DRUG | Single-dose, solution 2 x 60 mg morphine sulfate with sequestered 2.4 mg Naltrexone hydrochloride whole capsules manually crushed and mixed with 150 ml artificially sweetened, non-carbonated beverage |
Inclusion Criteria: * Subject is a recreational opioid user who is NOT physically dependent on opioids based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) criteria, and the Naloxone Challenge. A recreational opioid user is defined as recreationall...
EMBEDA is being studied in the indication of nondependent opioid abuse, episodic. The completed Phase 1 trial evaluated abuse potential of orally administered crushed EMBEDA compared to crushed controlled-release morphine and placebo in non-dependent recreational opioid users. It is not described as approved for this use.
EMBEDA is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the company associated with the drug's clinical development program in nondependent opioid abuse, episodic.
EMBEDA is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are listed. The program is investigational and remains in clinical development.
EMBEDA has been studied in one completed Phase 1 trial, NCT01380093, titled Abuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid Users. It enrolled 80 participants in the United States and was randomized, double-blind, and placebo-controlled.