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Belbuca 300 µg · 1 trial · 1 indication
Respiratory drive was evaluated by measuring the Ventilatory Response to Hypercapnia (VRH) through assessment of the maximum decrease (Emax) in minute ventilation (mL/min) after administration of Belbuca, Oxycodone hydrochloride, and placebo.
| Arm | Type | Description |
|---|---|---|
| Treatment A: Belbuca 300 µg and oral placebo | EXPERIMENTAL | Subjects treated with Belbuca 300 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. |
| Treatment B: Belbuca 600 µg and oral placebo | EXPERIMENTAL | Subjects treated with Belbuca 600 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. |
| Treatment C: Belbuca 900 µg and oral placebo | EXPERIMENTAL | Subjects treated with Belbuca 900 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. |
| Treatment D: Oxycodone 30 mg and buccal placebo | ACTIVE_COMPARATOR | Subjects treated with Oxycodone 30 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. |
| Treatment E: Oxycodone 60 mg and buccal placebo | ACTIVE_COMPARATOR | Subjects treated with Oxycodone 60 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. |
| Treatment F: Oral Placebo and buccal placebo | PLACEBO_COMPARATOR | Subjects treated with oral placebo and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. |
| Name | Type | Description |
|---|---|---|
| Belbuca 300 µg | DRUG | Belbuca 300 µg buccal film |
| Belbuca 600 µg | DRUG | Belbuca 600 µg buccal film |
| Belbuca 900 µg | DRUG | Belbuca 900 µg buccal film |
| Oxycodone 30 mg | DRUG | Oxycodone 30 mg capsule |
| Oxycodone 60 mg | DRUG | Oxycodone 60 mg capsule |
| Placebo | DRUG | placebo buccal film and oral placebo |
Inclusion Criteria: 1. Male or female subjects 18 to 55 years of age, inclusive. 2. Subjects are in good health as indicated by medical history, PE, vital signs, oxygen saturation, clinical laboratory tests, and 12-lead ECG. A status of good health will be defined by the absence of evidence of any ...
Belbuca 300 µg has been studied for respiratory depression, specifically in a Phase 1 trial comparing respiratory drive after administration of Belbuca, oxycodone, and placebo. The trial enrolled healthy adult volunteers. Belbuca 300 µg is an investigational use of the product in this respiratory depression setting.
Belbuca 300 µg is developed by Collegium Pharmaceutical, Inc., which trades under the ticker COLL. Collegium Pharmaceutical is the company associated with the Belbuca product and sponsored the clinical trial evaluating the 300 µg dose in respiratory depression.
Belbuca 300 µg is in Phase 1 clinical development for respiratory depression. The single completed trial, NCT03996694, was a Phase 1 study. No active trials are currently listed for this specific 300 µg respiratory depression program.
Belbuca 300 µg has been evaluated in one completed clinical trial, NCT03996694, titled a single dose crossover study to compare respiratory drive after administration of Belbuca, oxycodone, and placebo. The trial was Phase 1, randomized, double blind, placebo controlled, and enrolled 19 participants in the United States.
Belbuca 300 µg is investigational for respiratory depression and has been studied in a Phase 1 trial. The completed study, NCT03996694, evaluated respiratory drive in healthy volunteers. This specific 300 µg respiratory depression indication has not been established as an approved use based on the available development information.