Combined Analyses of Phase 2 studies for ARX-01 Sufentanil NanoTab PCA System for the management of moderate to severe post-operative pain

References! • Sufentanil NanoTab 15 mcg was effective, safe, and welltolerated for treatment of moderate to severe post-operative pain in all three studies • Data combined from both double-blind studies demonstrate a significant difference drop-out rates due to inadequate analgesia compared to placebo, with an average of 16% for the 15 mcg group and 33% for the 10 mcg group (p=0.047) • AE rates did not differ between the 10 mcg and 15 mcg dosing groups • These data suggest that a single 15 mcg sufentanil NanoTab dosage strength with a fixed 20-minute lock-out is appropriate for use in a wide variety of post-operative patients • Patients using 15 mcg sufentanil NanoTabs averaged interdosing intervals of 70 – 100 minutes. Published studies of IV PCA morphine use post-operatively report interdosing intervals of 20 – 40 minutes10-12 • The Sufentanil NanoTab PCA System (15 mcg) offers patients a user-friendly, non-invasive method of post-operative patientcontrolled analgesia Conclusions! Abstract!