Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Buprenorphine marketed · 1 trial · 1 indication
Patient's overall satisfaction on Day 1 to Day 5 postdose. Marketed sublingual tablet (Marketed SL): Days 1 and 2; Fast dissolving tablet (FTD): Days 3, 4, and 5. Within 1 hour after complete dissolution of the tablet(s), overall satisfaction towards the study treatment was to be scored by the patient himself / herself using a 10-cm visual analogic scale (VAS) ranging from "Not at all satisfied" (score = 0) to "Totally satisfied" (score = 10).
| Arm | Type | Description |
|---|---|---|
| Buprenorphine hydrochloride | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Buprenorphine hydrochloride marketed sublingual tablet (Subutex) | DRUG | 8 mg or 16 mg daily, sublingual route on Days 1 and 2 |
| Buprenorphine hydrochloride fast dissolving tablet (FDT) | DRUG | 8 mg or 16 mg daily, sublingual route on Days 3, 4, and 5 |
Inclusion Criteria: * Patients must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent. * Patients must be at least (≥) 18 years of age, of either sex. * Patients treated for opioid dependence with Subutex®, with a stable d...
Buprenorphine marketed is used for the treatment of opioid dependency. It is a small molecule therapy developed by Indivior Pharmaceuticals, Inc. under the ticker INDV. The drug is also known as buprenorphine hydrochloride marketed sublingual tablet (Subutex). It is intended for patients with opioid dependence, as studied in a Phase 2 clinical trial.
Buprenorphine marketed targets the opioid receptors OPRK1 and OPRM1. It acts as an agonist at these receptors. OPRM1 is the mu-opioid receptor, and OPRK1 is the kappa-opioid receptor. This mechanism is relevant to its use in opioid dependency.
Buprenorphine marketed is developed by Indivior Pharmaceuticals, Inc., which trades under the ticker INDV. Indivior is the company responsible for the development of this sublingual tablet formulation of buprenorphine hydrochloride.
Buprenorphine marketed is in Phase 2 of clinical development. It is an investigational product and has not been approved by the FDA for the studied indication. The development stage is based on a completed Phase 2 trial in opioid-dependent subjects.
Buprenorphine marketed has been studied in one clinical trial: NCT01075971, titled "Study of Two Formulations of Buprenorphine HCl in Opioid-dependent Subjects on Buprenorphine Maintenance Therapy (Study P04451)." This Phase 2 trial was completed and enrolled 52 participants. It was an uncontrolled study without randomization or double-blinding.
Yes, buprenorphine marketed is also known as buprenorphine hydrochloride marketed sublingual tablet (Subutex). Subutex is a brand name for buprenorphine hydrochloride sublingual tablets. This alternative name is used interchangeably when referring to the same product developed by Indivior Pharmaceuticals, Inc.