Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INDV-6200 · 1 trial · 1 indication
The key parameter of the time of maximum concentration (Tmax) of buprenorphine will be evaluated.
| Arm | Type | Description |
|---|---|---|
| Depot buprenorphine (INDV-6200) | EXPERIMENTAL | Period 1 subjects will receive SL buprenorphine to confirm tolerance to product Period 2 subjects will receive depot buprenorphine |
| Placebo | PLACEBO_COMPARATOR | Period 1 subjects will receive SL buprenorphine to confirm tolerance to product Period 2 subjects will receive volume-matched placebo |
| Name | Type | Description |
|---|---|---|
| INDV-6200 | DRUG | Subjects will be randomized in a 3:1 ratio to receive either depot buprenorphine or volume-matched placebo |
| Placebo | DRUG | Subjects will be randomized in a 3:1 ratio to receive either depot buprenorphine or volume-matched placebo |
| SL Buprenorphine | DRUG | All subjects will receive SL buprenorphine as non-investigational IMP to confirm tolerability |
| Nalorex | DRUG | Both Periods will include series of nalorex administrations to antagonize potential opioid effects from buprenorphine |
Inclusion Criteria: 1. Healthy males or non-pregnant, non-lactating females 2. Body mass index of 18.0-33.0 kg/m2 or, if outside the range, considered not clinically significant by the Investigator 3. Willing and able to communicate and participate in the whole study 4. Provide written informed con...
INDV-6200 is an investigational small molecule being developed for the treatment of opioid-use disorder. It is a novel subcutaneous depot formulation of buprenorphine, designed for use in patients with this condition. The drug is currently in Phase 1 clinical development.
INDV-6200 is a novel subcutaneous depot formulation of buprenorphine. Buprenorphine is a partial opioid receptor agonist, which works by binding to opioid receptors in the brain to reduce cravings and withdrawal symptoms associated with opioid-use disorder.
INDV-6200 is being developed by Indivior Pharmaceuticals, Inc., a company listed on the stock exchange under the ticker INDV. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational drug for opioid-use disorder.
INDV-6200 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing for opioid-use disorder.
INDV-6200 has one completed Phase 1 clinical trial, identified as NCT03715634. This study evaluated a novel subcutaneous depot formulation of buprenorphine in 12 participants with opioid-use disorder. The trial was placebo-controlled and conducted in the United Kingdom.
INDV-6200 is a novel subcutaneous depot formulation of buprenorphine. While it contains buprenorphine as the active ingredient, it is a distinct investigational product designed for extended-release delivery. It is being developed specifically for the treatment of opioid-use disorder.