Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
oxycodone IR · 2 trials · 4 indications
SPID5 was calculated as the weighted (weights is taken as the number of hours elapsed since the previous measurement) sum of the PID collected up to 5 days. Pain intensity (PI) score is calculated as the average PI over the past 12 hours using an 11-point (0 to 10) numerical rating scale (NRS) where "0" is no pain and "10" is pain as bad as you can imagine. The difference between baseline PI at the qualifying period and current PI is pain intensity difference (PID).
The number of SBM over the 14-day IR treatment phase was determined from the Bowel Function Patient Diary and factored to enable a per week value to be used. An SBM is defined as any BM that has occurred without the use of a laxative, enema, suppository, or manual manipulation within the previous 24 hours.
Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief. The study was terminated prematurely due to slow enrollment after 108 of 600 subjects enrolled. Valid statistical conclusions cannot be made due to the low number of subjects.
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | Tapentadol IR (CG5503) 50mg for 14 days |
| 002 | EXPERIMENTAL | Tapentadol IR (CG5503) 75mg for 14 days |
| 003 | ACTIVE_COMPARATOR | oxycodone IR 10mg for 14 days |
| 004 | PLACEBO_COMPARATOR | placebo 1 capsule for 14 days |
| 005 | EXPERIMENTAL | Tapentadol ER (CG5503) flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day) |
| 006 | ACTIVE_COMPARATOR | oxycodone CR flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day) |
| 007 | PLACEBO_COMPARATOR | placebo Tablets and capsules 2 x a day for 28 days |
| Name | Type | Description |
|---|---|---|
| oxycodone CR | DRUG | flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day) |
| oxycodone IR | DRUG | 10mg for 14 days |
| Tapentadol ER (CG5503) | DRUG | flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day) |
| Tapentadol IR (CG5503) | DRUG | 50mg for 14 days |
| placebo | DRUG | 1 capsule for 14 days |
| tapentadol IR | DRUG | 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days |
Inclusion Criteria: * A clinical diagnosis of osteoarthritis of the hip or knee * End-stage degenerative joint disease * Eligibility for primary unilateral total or partial joint replacement surgery * Pain level moderate to severe and at such a level as to require daily doses of an opioid analgesic...
Oxycodone IR is an immediate-release opioid analgesic used to treat moderate to severe pain. In the clinical program described, it has been studied in patients with back pain and joint diseases, including arthritis and osteoarthritis, where rapid-onset pain relief is needed.
Oxycodone IR targets OPRM1, the mu-opioid receptor, and acts as an agonist at this receptor. Activation of OPRM1 produces analgesia by dampening pain signaling in the central nervous system, which underlies the drug's use in moderate to severe pain.
Oxycodone IR is developed by Johnson & Johnson, which trades under the ticker JNJ. The company has sponsored Phase 3 studies of the immediate-release formulation in pain associated with joint disease and in acute pain from vertebral compression fracture linked to osteoporosis.
Oxycodone IR has been evaluated in Phase 3 clinical development. The program includes completed Phase 3 trials, and no active trials are currently listed. It is an investigational asset in this development program rather than a newly approved product.
Oxycodone IR has been studied in two completed Phase 3 trials: NCT00784277, which compared constipation symptoms with tapentadol IR versus oxycodone IR in patients with end-stage joint disease, and NCT00771758, which compared tapentadol IR, oxycodone IR, and placebo in acute pain from vertebral compression fracture associated with osteoporosis.
No, oxycodone IR and tapentadol IR are different drugs. Oxycodone IR targets OPRM1 as an agonist, while tapentadol IR is a separate agent. The two were compared head to head in Phase 3 trials, including NCT00784277 and NCT00771758.