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Also known as buprenorphine hemiadipate HCl, naloxone HCl
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 drug being developed by Supernus Pharmaceuticals for opioid related disorder. It has been studied in a Phase 2 trial involving adults with opioid related disorder, including a transfer of subjects from Subutex or Suboxone to RBP-6300. It remains in clinical development.
RBP-6300 is developed by Supernus Pharmaceuticals, Inc., which trades on Nasdaq under the ticker SUPN. The company is the sponsor of the clinical program for RBP-6300 in opioid related disorder.
RBP-6300 is in Phase 2 development. One Phase 2 trial of RBP-6300 has been completed, and no active trials are currently listed. RBP-6300 is investigational and is not an approved therapy.
RBP-6300 has been studied in the Phase 2 trial NCT01582347, titled Transfer of Subjects From Subutex/Suboxone to RBP-6300. The completed trial enrolled 143 adults with opioid related disorder across Austria, Czechia, Germany, and Sweden, and was randomized, double-blind, and active-controlled.
The Phase 2 trial NCT01582347 was a randomized, double-blind, active-controlled study of RBP-6300 in opioid related disorder. It enrolled 143 participants aged 18 years and older of all sexes and did not include healthy volunteers. The study was conducted in Austria, Czechia, Germany, and Sweden and has been completed.