Approval Probability
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Adjusted LOA
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hydrocodone/acetaminophen · 3 trials · 2 indications
The change from the double-blind randomization baseline (DB baseline: the last assessment before first dose in the double-blind 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 an ANCOVA model.
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.
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 48 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 Hydrocodone/Acetaminophen Extended Release | EXPERIMENTAL | Hydrocodone/acetaminophen extended release, 2 tablets twice daily |
| Double-blind Hydrocodone/Acetaminophen Extended Release | EXPERIMENTAL | Hydrocodone/acetaminophen extended release, 1 tablet twice daily |
| Double-blind Placebo | PLACEBO_COMPARATOR | Placebo, 1 tablet twice daily |
| Placebo | PLACEBO_COMPARATOR | placebo, 1 oral tablet every 12 hours |
| Hydrocodone/Acetaminophen Extended Release | EXPERIMENTAL | hydrocodone/acetaminophen extended release, 1 oral tablet every 12 hours |
| Acetaminophen | ACTIVE_COMPARATOR | 1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses). |
| Morphine Extended Release | ACTIVE_COMPARATOR | 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses). |
| Morphine Extended Release / Acetaminophen | ACTIVE_COMPARATOR | 1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses). |
| Name | Type | Description |
|---|---|---|
| hydrocodone/acetaminophen extended release | DRUG | - |
| Placebo | DRUG | - |
| Acetaminophen | DRUG | - |
| Morphine Extended Release | DRUG | - |
Inclusion Criteria: Adult subjects who have a diagnosis of chronic low back pain of at least 6 month duration Exclusion Criteria: Subjects with a history of surgical or invasive intervention
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 2 | PHASE3 | Camlipixant |
| Trevi Therapeutics, Inc. | TRVI | 1 | PHASE2 | Haduvio (nalbuphine ER) |
Hydrocodone/acetaminophen is a small molecule combination pain therapy being developed by AbbVie Inc. (ticker ABBV). It is under investigation for chronic low back pain and pain generally, and it has been studied in Phase 2 clinical trials. The combination pairs hydrocodone, an opioid analgesic, with acetaminophen, a non-opioid analgesic.
Hydrocodone/acetaminophen is being studied for the treatment of chronic low back pain and pain. AbbVie Inc. has evaluated the combination in Phase 2 trials, including a chronic low back pain study and acute pain studies following bunionectomy. It is an investigational product and is not described as approved for these uses.
Hydrocodone/acetaminophen targets PTGS2, PTGS1, FAAH, and TRPV1. It is classified as an inhibitor. PTGS1 and PTGS2 are cyclooxygenase enzymes associated with acetaminophen's analgesic activity, while FAAH and TRPV1 are pain signaling targets. The drug is a small molecule combination developed by AbbVie Inc. (ABBV).
Hydrocodone/acetaminophen is developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the sponsor behind the clinical program evaluating the combination in chronic low back pain and pain. The asset is a small molecule therapy and remains in Phase 2 development.
Hydrocodone/acetaminophen is in Phase 2 development. Both completed studies in the program are Phase 2 trials, and no active trials are currently listed. The program has enrolled approximately 350 participants across randomized, double-blind, placebo-controlled studies. It is an investigational therapy and is not described as FDA approved.
Hydrocodone/acetaminophen has been studied in completed Phase 2 trials, including NCT01364922 in chronic low back pain, NCT01333722 in acute pain following bunionectomy, and NCT01038609 in acute pain following bunionectomy. All were conducted in the United States, were randomized, double-blind, and placebo-controlled, and enrolled adults 18 years and older.