Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Intravenous meloxicam
N1539 · 6 trials · 2 indications
Total use of opioid analgesia, in IV morphine equivalent dose, from Hour 0 through 24.
Evaluate the incidence of adverse events in subjects receiving N1539 30 mg vs. placebo prior to colorectal surgery
Number of subjects reporting 1 or more treatment-emergent adverse events
Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID value (i.e. more negative) was better.
Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID value (i.e. more negative) was better.
| Arm | Type | Description |
|---|---|---|
| N1539 30 mg | EXPERIMENTAL | N1539 (meloxicam injection for IV use) 30 mg every 24 hours |
| IV Placebo | PLACEBO_COMPARATOR | IV Placebo every 24 hours |
| N1539 30mg | EXPERIMENTAL | N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 7 doses. |
| N1539 60mg | EXPERIMENTAL | N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses. |
| Name | Type | Description |
|---|---|---|
| N1539 | DRUG | Once Daily |
| Placebo | DRUG | Once Daily |
| Intravenous Placebo | DRUG | - |
Inclusion Criteria: * Voluntarily provide written informed consent. * Be planned to undergo an elective, primary (no repeat arthroplasties) open unilateral total knee arthroplasty (TKA), and be expected to require IV analgesia, remain in an inpatient setting for ≥24 hours, and receive at least two ...
Top 2 of 24 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE2 | LY4515100 |
| Pfizer Inc. | PFE | 1 | N/A | Palbociclib |