Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NUCYNTA · 1 trial · 4 indications
Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 120 hours.
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | NUCYNTA 50 75 or 100 mg every 4 to 6 hours for up to 10 days as needed for pain |
| 002 | ACTIVE_COMPARATOR | Oxycodone IR 5 10 or 15 mg every 4 to 6 hours for up to 10 days as needed for pain |
| Name | Type | Description |
|---|---|---|
| NUCYNTA | DRUG | 50, 75, or 100 mg every 4 to 6 hours for up to 10 days as needed for pain |
| Oxycodone IR | DRUG | 5, 10, or 15 mg every 4 to 6 hours for up to 10 days as needed for pain |
Inclusion Criteria: * At Visit 1 (study entry) patients must have a medical history and physical and neurological examinations that support a clinical diagnosis of acute low back pain that is felt down to the lower leg below the knee with the onset no longer than 30 days before Visit 1 * At Visit 1...
NUCYNTA is used for the treatment of pain, specifically acute low back pain. It is a small molecule being developed by Johnson & Johnson for musculoskeletal pain conditions. The drug is currently in Phase 3 clinical development and is being studied in patients with low back pain, including back pain with radiation.
NUCYNTA is a small molecule that targets pain pathways. It is being studied for its analgesic effects in the treatment of acute low back pain. The drug is being compared to oxycodone immediate release in a clinical trial to evaluate its efficacy and safety in managing pain.
NUCYNTA is being developed by Johnson & Johnson, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating acute low back pain.
NUCYNTA is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is being studied in a completed Phase 3 trial for the treatment of acute low back pain, with results expected to inform further development.
NUCYNTA has been studied in one completed Phase 3 clinical trial, identified as NCT00986180. This trial compared NUCYNTA (tapentadol immediate release) to oxycodone immediate release in the treatment of acute low back pain. The study enrolled 667 participants in the United States and was randomized, double-blind, and active-controlled.
NUCYNTA is the brand name for tapentadol immediate release. The clinical trial NCT00986180 explicitly refers to NUCYNTA as tapentadol immediate release, confirming that NUCYNTA and tapentadol are the same drug. This medication is being evaluated for its analgesic properties in treating acute low back pain.