TABLE 2 

Drug Liking VAS Emax and Emin following oral or intranasal drug administration (PD analysis sets)

Oral Administration
ParameterStatisticPBO 
(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 EmaxMean (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)
Median51.088.0100.051.051.551.0
Median difference (IQR)
versus PBO34.5 (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 EminMean (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)
Median50.050.050.050.050.050.0
Median difference (IQR)
versus PBO0.0 (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 mg0.0 (–1.0, 0.0) *0.0 (­–2.0, 0.0) *0.0 (­–16.0, 0.0) **
versus OXY IR 60 mg0.0 (–1.0, 0.0)0.0 (­–1.0, 0.0)0.0 (­–16.0, 0.0)
Intranasal Administration
ParameterStatisticPBO 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 EmaxMean (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)
Median51.051.081.095.051.051.0
Median difference (IQR)
versus PBO lactose0.0 (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 ELX0.0 (–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 EminMean (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)
Median50.049.050.050.00.00.0
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.