Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RBP-8000 · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| RBP-8000 100mg/Placebo | EXPERIMENTAL | Day 1: 50mg intravenous infusion of cocaine Day 3: 50mg intravenous infusion of cocaine followed by a 100mg intravenous infusion of RBP-8000 Day 6: 50mg intravenous infusion of cocaine followed by an intravenous infusion of placebo |
| Placebo/RBP-8000 100mg | EXPERIMENTAL | Day 1: 50mg intravenous infusion of cocaine Day 3: 50mg intravenous infusion of cocaine followed by an intravenous infusion of placebo Day 6: 50mg intravenous infusion of cocaine followed by a 100mg intravenous infusion of RBP-8000 |
| RBP-8000 200mg/Placebo | EXPERIMENTAL | Day 1: 50mg intravenous infusion of cocaine Day 3: 50mg intravenous infusion of cocaine followed by a 200mg intravenous infusion of RBP-8000 Day 6: 50mg intravenous infusion of cocaine followed by an intravenous infusion of placebo |
| Placebo/RBP-8000 200mg | EXPERIMENTAL | Day 1: 50mg intravenous infusion of cocaine Day 3: 50mg intravenous infusion of cocaine followed by an intravenous infusion of placebo Day 6: 50mg intravenous infusion of cocaine followed by a 200mg intravenous infusion of RBP-8000 |
| Name | Type | Description |
|---|---|---|
| RBP-8000 100 mg | DRUG | RBP-8000 100 mg administered in the vein on either study day 3 or 6. There is a 72-hour washout between Days 3 and 6 |
| Placebo | DRUG | IV infusion of Placebo administered 1 minute after cocaine infusion on either day 3 or 6. |
| Cocaine | DRUG | 50 mg intravenous (IV) dose of cocaine administered over 10 minutes on Days 1, 3 and 6. |
| RBP-8000 200 mg | DRUG | RBP-8000 200 mg administered in the vein on either study day 3 or 6. There is a 72-hour washout between Days 3 and 6 |
Inclusion Criteria: * Male and female volunteers aged 21-50 years, inclusive * Body mass index (BMI)18-32 kg/m\^2 and weight of at least 50 kg * Not currently seeking treatment for substance abuse or substance dependence * Subject is healthy, in the opinion of the Principal Investigator other than ...
RBP-8000 is an investigational small-molecule drug being studied for opioid dependence, including opioid-related disorders. A Phase 2 study also enrolled participants with cocaine dependence. It is being developed by Supernus Pharmaceuticals, Inc. and has not been established as an approved treatment.
RBP-8000 is developed by Supernus Pharmaceuticals, Inc., which trades on Nasdaq under the ticker SUPN. The company is the sponsor behind the drug's clinical development program in psychiatry, focused on opioid dependence.
RBP-8000 is in Phase 2 clinical development. It is an investigational small-molecule drug and is not FDA approved. One Phase 2 trial has been completed, and no trials are currently active.
RBP-8000 has been studied in one completed Phase 2 trial, NCT01846481. It was a randomized, four-sequence, two-period, double-blind, placebo-controlled study in participants with a DSM-IV-TR diagnosis of cocaine abuse, also covering opioid dependence and opioid-related disorders. It enrolled 40 participants in the United States.
The completed Phase 2 trial, NCT01846481, was a randomized, double-blind, placebo-controlled study with a four-sequence, two-period design. It enrolled 40 participants aged 21 years and older of all sexes, including healthy volunteers, and was conducted in the United States.