TABLE 2 .
Drug Liking VAS Emax and Emin following oral or intranasal drug administration (PD analysis sets)
|
Oral Administration | |||||||
|---|---|---|---|---|---|---|---|
| Parameter | Statistic | PBO (n = 37) | OXY IR 30 mg (n = 37) | OXY IR 60 mg (n = 37) | ELX 100 mg (n = 35) | ELX 300 mg (n = 36) | ELX 1000 mg (n = 35) |
| Drug Liking VAS Emax | Mean (S.D.) | 54.3 (9.5) | 85.8 (14.3) | 90.9 (11.5) | 56.8 (13.7) | 58.7 (13.4) | 60.0 (14.8) |
| Median | 51.0 | 88.0 | 100.0 | 51.0 | 51.5 | 51.0 | |
| Median difference (IQR) | |||||||
| versus PBO | — | 34.5 (23.5, 45.5) *** | 41.0 (25.0, 49.0) *** | 0.0 (–1.0, 1.0) | 0.0 (0.0, 9.0) * | 0.0 (0.0, 12.0) * | |
| versus OXY IR 30 mg | — | — | — | −35.0 (–45.0, –24.0) *** | −31.0 (–43.0, –17.0) ** | −33.0 (–45.0, –16.0) ** | |
| versus OXY IR 60 mg | — | — | — | −37.0 (–49.0, –26.0) *** | −33.0 (–49.0, –20.0) *** | −35.0 (–49.0, –21.0) *** | |
| Drug Liking VAS Emin | Mean (S.D.) | 46.5 (11.8) | 48.6 (5.8) | 42.5 (15.0) | 45.0 (14.2) | 44.9 (11.1) | 38.3 (19.6) |
| Median | 50.0 | 50.0 | 50.0 | 50.0 | 50.0 | 50.0 | |
| Median difference (IQR) | |||||||
| versus PBO | — | 0.0 (0.0, 0.0) | 0.0 (–1.0, 0.0) | 0.0 (–1.0, 0.0) | 0.0 (–2.0, 0.0) | 0.0 (–14.0, 0.0) ** | |
| versus OXY IR 30 mg | — | — | — | 0.0 (–1.0, 0.0) * | 0.0 (–2.0, 0.0) * | 0.0 (–16.0, 0.0) ** | |
| versus OXY IR 60 mg | — | — | — | 0.0 (–1.0, 0.0) | 0.0 (–1.0, 0.0) | 0.0 (–16.0, 0.0) | |
| Intranasal Administration | |||||||
| Parameter | Statistic | PBO lactose (n = 32) | PBO ELX (n = 34) | OXY IR 15 mg (n = 32) | OXY IR 30 mg (n = 32) | ELX 100 mg (n = 32) | ELX 200 mg (n = 32) |
| Drug Liking VAS Emax | Mean (S.D.) | 49.1 (9.0) | 52.2 (9.1) | 79.5 (22.0) | 88.7 (14.6) | 53.2 (21.7) | 54.9 (21.0) |
| Median | 51.0 | 51.0 | 81.0 | 95.0 | 51.0 | 51.0 | |
| Median difference (IQR) | |||||||
| versus PBO lactose | — | 0.0 (0.0, 0.0) | 36.0 (16.5, 49.0) *** | 47.0 (28.0, 49.0) *** | 0.0 (–1.0, 2.0) | 0.0 (–1.0, 20.0) | |
| versus PBO ELX | — | — | — | — | 0.0 (–1.0, 1.0) | 0.0 (0.0, 12.0) | |
| versus OXY IR 15 mg | — | — | — | — | −28.0 (–48.0, -12.0) *** | −26.0 (–48.0, -9.0) *** | |
| versus OXY IR 30 mg | — | — | — | — | −45.0 (–49.0, -26.0) *** | −42.0 (–49.0, -11.0) *** | |
| Drug Liking VAS Emin | Mean (S.D.) | 45.3 (14.3) | 38.1 (19.2) | 48.1 (16.3) | 45.6 (16.9) | 16.4 (21.7) | 12.4 (20.1) |
| Median | 50.0 | 49.0 | 50.0 | 50.0 | 0.0 | 0.0 | |
| LS mean difference (S.E.) | |||||||
| versus PBO lactose | — | −6.7 (4.1) | 2.7 (4.2) | 0.1 (4.2) | −28.4 (4.2) *** | −33.0 (4.20) *** | |
| versus PBO ELX | — | — | — | — | −21.7 (4.1) *** | −26.3 (4.1) *** | |
| versus OXY IR 15 mg | — | — | — | — | −31.1 (4.2) *** | −35.7 (4.2) *** | |
| versus OXY IR 30 mg | — | — | — | — | −28.5 (4.2) *** | −33.1 (4.2) *** | |
ELX, eluxadoline; IQR, interquartile range; OXY IR, oxycodone immediate release; PBO, placebo.
*
P < 0.05, **P < 0.01, and ***P < 0.0001.