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ABT-712 · 3 trials · 2 indications
The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from 2-way ANCOVA model without interaction.
Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning "no pain" and 100 meaning the "worst pain imaginable". The SPID VAS score for 0 to 12 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.
| Arm | Type | Description |
|---|---|---|
| Open-label ABT-712 | EXPERIMENTAL | 2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period). |
| Double-blind ABT-712 | EXPERIMENTAL | 2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period). |
| Double-blind Placebo | PLACEBO_COMPARATOR | 2 placebo tablets, twice daily, for 4 weeks (double-blind period). |
| ABT-712 | EXPERIMENTAL | 1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses). |
| Hydrocodone/Acetaminophen | ACTIVE_COMPARATOR | 2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses). |
| Placebo | PLACEBO_COMPARATOR | 2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses). |
| Name | Type | Description |
|---|---|---|
| ABT-712 | DRUG | ABT-712 extended-release tablet |
| Placebo | DRUG | Placebo tablet |
| ABT-712 Extended-release | DRUG | ABT-712 extended-release tablet |
| Hydrocodone/Acetaminophen Immediate-release | DRUG | Hydrocodone/acetaminophen immediate-release tablet |
Inclusion Criteria: * Adult male and female subjects who voluntarily sign the informed consent * Diagnosis of CLBP of 6 months duration Exclusion Criteria: * Incapacitated or bedridden subjects * Subjects with history of surgical or invasive intervention
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ABT-712 is an investigational small molecule being developed for chronic low back pain. It is intended for patients with moderate to severe chronic low back pain. The drug is currently in Phase 3 clinical development and has not been approved by the FDA.
ABT-712 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie is conducting the clinical trials for this investigational drug.
ABT-712 is in Phase 3 clinical development. Two Phase 3 trials have been completed, both evaluating the safety and efficacy of the drug in subjects with moderate to severe chronic low back pain. It remains investigational and is not FDA approved.
ABT-712 has been studied in two completed Phase 3 trials: NCT00761150 with 308 participants and NCT00763321 with 287 participants. Both were randomized, double-blind, placebo-controlled studies conducted in the United States in patients with chronic low back pain.
No, ABT-712 is not FDA approved. It is an investigational drug that has completed Phase 3 clinical trials for chronic low back pain. The trials were randomized, double-blind, and placebo-controlled, but the drug has not received regulatory approval.