Parameter, Units Parameter Summary Statistics1 for Oxycodone by Treatment   ALO-02 40 mg IRO 20 mg No. of participants 13 13 AUCinf, ng∙h/mL 508.8 (29) 238.8 (23) AUCinf(dn), ng∙h/mL/mg 12.71 (29) 11.93 (23) AUClast, ng∙h/mL 496.2 (29) 235.5 (23) AUClast(dn), ng∙h/mL/mg 12.41 (29) 11.78 (23) C24, ng/mL 11.57 (37) 0.69 (61) Cmax, ng/mL 26.57 (24) 40.12 (25) Cmax(dn), ng/mL/mg 0.66 (24) 2.01 (25) Tmax, h 12.0 (8.0–16.0) 1.0 (0.5–2.0) t1/2, h 7.21 ±0.96 4.58 ±1.20

ALO-02: extended-release oxycodone hydrochloride with sequestered naltrexone hydrochloride; AUCinf: area under the curve from time zero extrapolated to infinity; AUClast: area under the curve from time zero to the time of the last quantifiable concentration; C24: concentration at 24 hours post dose; Cmax: maximum plasma concentration; CV: coefficient of variation; dn: dose-normalized to 1 mg; IRO: immediate-release oxycodone; N: total number of participants in the treatment group and contributing to the mean; SD: standard deviation; t1/2: terminal half-life; Tmax: time to reach maximum concentration. 1 Geometric mean (geometric % coefficient of variation) for all except: median (range) for Tmax and arithmetic mean ± SD for t1/2.

Table 1: Plasma oxycodone pharmacokinetic parameters following single oral doses of ALO-02 40 mg capsules and IRO 20 mg tablets.