Shots:

• The approval is based on two P-III study (N=610- XARACOLL Arm N=404; PBO Arm N=206) performed as outpatient surgeries in adults across 39 sites in the US.
• Result: Xaracoll provided statistically significant pain relief through 24 hrs. vs PBO- the primary endpoint for both studies. Median time in study 1 (11hrs. vs 1 hrs.) and in study 2 (6hrs. vs 1 hrs.)
• Xaracoll is a unique- non-injectable drug-device combination in the form of a fully bioresorbable collagen implant containing bupivacaine hydrochloride which is placed directly into the surgical site during surgery and- after placement- releases bupivacaine immediately and over time

­ Ref: Stifel | Image: Stifel