Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Acurox 5
Acurox 5/ taken first · 2 trials · 2 indications
Time weighted Sum of Pain Intensity Differences over the first 48 hours (SPID48) is the sum of the Pain Intensity Difference (PID) scores observed at 0.5 , 1, 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42, and 48 hours post-dose. Pain Intensity scores at each timepoint are based on a 100 mm visual analog scale (VAS) from 0 = no pain to 100 = worst pain imaginable. PID is calculated as the timepoint score less the baseline pre-dose score (i.e. PID.5 = PI.5 - PI0). SPID48 = the PID for each timepoint multiplied by a time weighting factor; which is the difference (in hours) between the PID observation and prior observation. SPID48 = PID.5\*.5 + PID1\*.5 + PID2\*1 + PID3\*1 + PID4\*1 + PID6\*2 +PID12\*6 + PID18\*6 +PID24\*6 + PID30\*6 + PID36\*6 + PID42\*6 + PID48\*6. The maximum SPID48 value is 4,800 (assumes PI0 of 100 and a PI of 0 at all subsequent timepoints) with a midpoint SPID48 of 2,400 (PI0=50 and PI of 0 at all subsequent readings).
"Do you dislike or like the drug effect you are feeling now?" This question was rated on a 1 to 29 point VAS scale that was anchored in the center with "neither like nor dislike" (14), on the left with "dislike an awful lot" (1), and on the right with "like an awful lot" (29).
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Tablet |
| Acurox 5/30mg | ACTIVE_COMPARATOR | Oxycodone HCl 5mg/Niacin 30mg tablet |
| Acurox 7.5/30 | PLACEBO_COMPARATOR | Oxycodone HCl 7.5mg/Niacin 30mg tablet |
| Acurox 5/30mg taken first | ACTIVE_COMPARATOR | oxycodone HCl/Niacin 5/30mg tablets; 8 tablets per dose |
| Oxycodone 5mg taken first | ACTIVE_COMPARATOR | oxycodone HCl 5mg tablets; 8 tablets per dose |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | 2 tablets every 6 hours for 48 hours |
| Acurox 5/30 mg | DRUG | 2 tablets every 6 hours for 48 hours |
| Acurox 7.5/30 | DRUG | 2 tablets every 6 hours for 48 hours |
| Acurox 5/30mg taken first | DRUG | followed by oxycodone 5mg with 48 hour washout |
| Oxycodone 5mg taken first | DRUG | followed by Acurox 5/30mg with 48 hour washout |
Inclusion Criteria: * Patient is male or female at least 18 years of age * For women of child-bearing potential: woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control * Patient is scheduled to have a bunionectomy * Patient must be willing to stay at ...