Pacira's Exparel misses in Phase III TKA nerve block trial

Pacira Pharmaceuticals Inc. (NASDAQ:PCRX) reported top-line data from a Phase III trial in 232 patients undergoing total knee arthroplasty (TKA) showing that 133 and 266 mg Exparel bupivacaine given as a single-dose femoral nerve block at least 1 hour prior to surgery each missed the primary endpoint of improving cumulative pain scores over 72 hours as measured by the area under the curve (AUC) vs. placebo (p>0.05). The company attributed the miss to a "significant deviation from protocol" identified at a single trial site.

On a conference call, Pacira said the "high enroller" site had surgeons "who did not understand the protocol." According to the company, a "meaningful number" of patients did not receive free bupivacaine administration into the knee posterior capsule as required by the protocol. When these patients were excluded from the analyses, Pacira said high-dose Exparel would have met the primary endpoint vs. placebo (p<0.03)...