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Also known as Probuphine (buprenorphine implant)
Probuphine · 4 trials · 2 indications
AEs that occurred after the signing of the informed consent until 4 weeks after the implants have been removed were followed. Serious AEs and AEs that were designated as possibly related to study drug were followed until resolution or stabilization.
Adverse events that occurred after the signing of the informed consent until 14 days after study drug treatment has been discontinued, or AEs designated as possibly-related to study drug and all Serious AEs until resolution or stabilization, were followed.
| Arm | Type | Description |
|---|---|---|
| Probuphine | EXPERIMENTAL | patients are first inducted on sublingual buprenorphine then switched to 4 Probuphine Implants |
| placebo implant | PLACEBO_COMPARATOR | patients are first inducted on SL BPN then switched to 4 placebo implants |
| sublingual buprenorphine | ACTIVE_COMPARATOR | patients are inducted on SL BPN, then continue on SL BPN |
| Group A | ACTIVE_COMPARATOR | - |
| Group B | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Probuphine (buprenorphine implant) | DRUG | Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. |
| placebo implant | DRUG | Implant contains ethylene vinyl acetate |
| Buprenorphine | DRUG | sublingual buprenorphine/naloxone tablets |
| Probuphine | DRUG | 4 implants |
| placebo | DRUG | 4 implants |
Inclusion Criteria: * Subject has voluntarily provided written informed consent prior to conducting any study-related procedures * Completion of 24 weeks of treatment in PRO-806 * Subject has been deemed appropriate for entry into this extension study by the investigator * Females of childbearing p...
Probuphine is used for the treatment of opioid dependence, also referred to as opioid dependency. It is being developed as a small molecule therapy in the psychiatry therapeutic area. The clinical program has studied it in adults aged 18 years and older with opioid dependence in the United States.
Probuphine is being developed by Titan Pharmaceuticals, Inc., which trades under the ticker TTNP. The company has sponsored the Phase 3 clinical program evaluating Probuphine in opioid dependence, including randomized, double-blind, placebo-controlled trials conducted in the United States.
Probuphine is in Phase 3 clinical development for opioid dependence. Its trials are listed as Phase 3 studies, and the completed trials include randomized, double-blind, placebo-controlled designs. The program has enrolled a total of 372 participants across its clinical studies.
Probuphine has been studied in completed Phase 3 trials including NCT01114308, a six-month randomized controlled trial of safety and efficacy in opioid addiction with 287 participants, and NCT01262261, a re-treatment study in opioid addiction with 85 participants. Additional completed studies include NCT00630201 and NCT00447564.
Yes, Probuphine is also known as the buprenorphine implant. Searches for either name refer to the same product candidate being developed by Titan Pharmaceuticals, Inc. for opioid dependence. It is a small molecule therapy studied in Phase 3 clinical trials.