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RBP-6300 · 1 trial · 1 indication
To demonstrate that RBP-6300 is not inferior to Subutex/Suboxone as assessed by the peak change from baseline in the pre-dose COWS score during the double-blind transfer phase
| Arm | Type | Description |
|---|---|---|
| RBP-6300 | EXPERIMENTAL | During the Double-Blind Transfer Period (Days 1-7), participants take RBP-6300 at a level (either 10, 20 or 30 mg/day) equivalent to dosing during the Run-In Period, plus Placebo for Subutex®/Suboxone®. This is followed by a 3-day Transition Period (Days 8-10) in which participants take active Subutex®/Suboxone® equal to the dose taken during the Run-In Period plus placebo matching RBP-6000. |
| Subutex®/Suboxone® | ACTIVE_COMPARATOR | During the Double-Blind Transfer Period (Days 1-7), participants take Subutex®/Suboxone® at a level (either 8, 16 or 240 mg/day) equivalent to dosing during the Run-In Period, plus Placebo for RBP-6000. This is followed by a 3-day Transition Period (Days 8-10) in which participants take active Subutex®/Suboxone® equal to the dose taken during the Run-In Period plus placebo matching RBP-6000. |
| Name | Type | Description |
|---|---|---|
| RBP-6300 | DRUG | Participants randomized to the RBP-6300 treatment arm take either 10, 20 or 30 mg/day RBP-6300 tablets during the Transfer Period (study days 1-7). Oral RBP-6300 tablets containing 10 mg buprenorphine hemiadipate HCl and 10 mg naloxone HCl dehydrate. |
| Subutex®/Suboxone® | DRUG | Participants randomized to the Subutex®/Suboxone® treatment arm take the dosage of either drug on which they were previously stabilised during the Run-In, Transfer, and Transition Periods. Participants randomized to the RBP-6300 treatment arm take the dosage of either drug on which they were previously stabilised during the Run-In and Transition Periods. Sublingual Subutex® tablets containing 8 mg buprenorphine and and sublingual Suboxone® tablets containing 8 mg buprenorphine and 2 mg naloxone. |
| Placebo for RBP-6300 | DRUG | Participants randomized to the Subutex®/Suboxone® treatment arm take Placebo for RBP-6300 during the Transfer and Transition Periods. Participants randomized to the RBP-6300 treatment arm take Placebo for RBP-6300 during the Transition Period. |
| Placebo for Subutex®/Suboxone® | DRUG | Participants randomized to the RBP-6300 treatment arm take Placebo for Subutex®/Suboxone® during the Transfer Period. |
Inclusion Criteria: * Be Male or non-pregnant, non-lactating females * Be at least 18 years of age * Meet Diagnostic and Statistical Manual of Mental Disorders, DSM-IV-TR (Diagnostic and Statistical Manual-IV-TEXT REVISION)criteria for opioid dependence at screening * Be on stable dose of 8, 16, or...
RBP-6300 is an investigational small molecule being developed for the treatment of Opioid Related Disorder. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities. The drug is being studied as a potential treatment option for patients with this condition.
RBP-6300 is being developed by Indivior Pharmaceuticals, Inc., a company listed on the stock exchange under the ticker symbol INDV. Indivior is responsible for the clinical development and regulatory strategy for this investigational drug candidate.
RBP-6300 is currently in Phase 2 clinical development. It is an investigational drug and has not received regulatory approval. The completed Phase 2 trial represents an early stage of clinical testing, and further studies would be needed to establish its safety and efficacy.
RBP-6300 has one completed Phase 2 clinical trial registered under NCT01582347, titled "Transfer of Subjects From Subutex/Suboxone to RBP-6300." This randomized, double-blind, active-controlled study enrolled 143 participants with Opioid Related Disorder across Austria, Czechia, Germany, and Sweden.
No, RBP-6300 is a distinct investigational drug candidate developed by Indivior. The clinical trial NCT01582347 studied the transfer of subjects from Subutex or Suboxone to RBP-6300, indicating that RBP-6300 is being evaluated as a potential alternative or follow-on treatment for Opioid Related Disorder.