Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational small molecule being developed for the treatment of opioid dependence and opioid dependency. It is in Phase 3 clinical development and has not been approved by the FDA. The drug is intended for adult patients aged 18 years and older.
Probuphine is being developed by Titan Pharmaceuticals, Inc., a company listed on the stock exchange under the ticker symbol TTNP. Titan Pharmaceuticals is conducting clinical trials to evaluate the safety and efficacy of Probuphine for the treatment of opioid dependence.
Probuphine is in Phase 3 clinical development. It is an investigational drug and has not received FDA approval. Multiple Phase 3 trials have been completed to assess its safety and efficacy in treating opioid dependence and opioid dependency.
Probuphine has been studied in several completed Phase 3 clinical trials, including NCT00447564, NCT00630201, NCT01114308, and NCT01262261. These trials evaluated the drug's safety and efficacy in treating opioid dependence and opioid dependency in the United States, with enrollment ranging from 62 to 287 participants.
Probuphine is a distinct drug product developed by Titan Pharmaceuticals for opioid dependence. It is not the same as generic buprenorphine, as Probuphine is a specific formulation being tested in clinical trials. The drug is administered to adults aged 18 years and older.