Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tapentadol PR · 1 trial · 2 indications
Percentage of participants with sustained pain control for 5 day fixed dose phase were the participants who completed 5 day maintenance period, whose mean Numerical Rating Scale (NRS) score during the fixed dose phase and which was assessed immediately before giving each dose was less than 4 and the number of rescue doses per day for fixed dose phase was 2 or less. Pain intensity scores were recorded 0 to 30 minutes before dose on 11 point NRS where 0 = no pain and 10 = severest pain imaginable.
| Arm | Type | Description |
|---|---|---|
| Opioid-Naive Participants (Tapentadol PR) | EXPERIMENTAL | Opioid-naive participants are defined as those who had moderate to severe cancer pain that is not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) is duration between start of treatment to day before initial dose in the maintenance period. Treatment will be initiated with tapentadol prolonged release (JNS024PR, PR) 25 milligram (mg) oral tablet twice daily. Dose will be increased or decreased as per Investigator's discretion up to Day 14. Maximum dose limit will be 500 mg per day. Participants will then be assigned to the treatment in the maintenance period (15-19 days). The maintenance period is duration between the first dose and the final assessment in the maintenance period. Participants will receive tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period. |
| Opioid-Switch Participants (Tapentadol PR) | EXPERIMENTAL | Opioid-switching participants are defined as those who had moderate to severe cancer pain that is controlled sufficiently with opioid therapy. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) is duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR is selected according to daily dose of opioid (morphine sustained release \[SR\] preparation, oxycodone hydrochloride \[HCl\] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily is given depending on daily dose of opioid at completion of Screening period. Maximum dose limit is 500 mg per day. Participants will then be assigned to treatment in maintenance period (15-19 days). Maintenance period is defined as duration between first dose and final assessment in maintenance period. Participants will receive tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period. |
| Name | Type | Description |
|---|---|---|
| Tapentadol PR | DRUG | Tapentadol PR tablets will be administered orally twice daily initiated at dose of 25 mg. Dose will be adjusted as per Investigator's discretion. Maximum dose limit is 500 mg per day. Total duration of treatment is 19 days. |
Inclusion Criteria: * Opioid switching participants should meet the following criteria from a to c: a) Participants with cancer pain b) previously were on opioid medications (morphine sustained release preparations \[120 milligram per day {mg/day} or less\], oxycodone hydrochloride sustained releas...
Tapentadol PR is an investigational prolonged-release formulation being studied for the treatment of pain, including cancer-related pain. It is being developed by Johnson & Johnson. The completed Phase 2 trial enrolled participants with pain and cancer in Japan.
Tapentadol PR targets SLC6A2 and OPRM1. It acts as an inhibitor at these targets, combining norepinephrine reuptake inhibition with mu-opioid receptor activity to produce analgesic effects.
Tapentadol PR is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company is responsible for the clinical development of this prolonged-release pain therapy.
Tapentadol PR is in Phase 2 clinical development. It is investigational and has not been approved by the FDA for any indication. The Phase 2 trial for cancer pain has been completed.
Tapentadol PR has been studied in one completed Phase 2 trial, NCT00805142, titled Phase 2 Study of Tapentadol Prolonged Release in Cancer Pain Participants. The trial enrolled 78 participants in Japan and included a controlled design.