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 drug being developed by Supernus Pharmaceuticals for opioid-use disorder. It is a novel subcutaneous depot formulation of buprenorphine, designed as a long-acting injectable option. It is in Phase 1 clinical development and has not been approved by the FDA.
INDV-6200 is being developed for the treatment of opioid-use disorder as a subcutaneous depot formulation of buprenorphine. The depot design is intended to deliver buprenorphine as a long-acting injectable. Its clinical program to date consists of a single completed Phase 1 study conducted in the United Kingdom.
INDV-6200 is being developed by Supernus Pharmaceuticals, Inc., which trades on Nasdaq under the ticker SUPN. Supernus is the sponsor of the drug's clinical program in opioid-use disorder, including the completed Phase 1 study of the subcutaneous depot formulation of buprenorphine.
INDV-6200 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for opioid-use disorder or any other indication. One Phase 1 trial has been completed, and no active trials of INDV-6200 are currently listed.
INDV-6200 has been studied in one completed Phase 1 trial, NCT03715634, titled Study of a Novel Subcutaneous Depot Formulation of Buprenorphine. The trial enrolled 12 participants, including healthy volunteers, in the United Kingdom, with participants aged 18 years and older. It was randomized and placebo-controlled.