Pacira Pharmaceuticals, Inc. (PCRX) Thursday said results from a late-stage study with Exparel in intercostal nerve block did not meet the primary endpoint of pain reduction. The stock plunged 12 percent in the extended trade.
The company's second pivotal, Phase 3 clinical trial assessed the safety and efficacy of Exparel (bupivacaine liposome injectable suspension) in intercostal nerve block for a surgical procedure known as posterolateral thoracotomy. The study did not achieve its main goal of a reduction of cumulative pain scores over 72 hours.
Exparel is currently indicated for single-dose administration into the surgical site to produce postsurgical analgesia. It has broad applications across a wide range of surgical specialties from general, colorectal, and orthopedic surgery to bariatric and plastic surgery procedures.
The 180 patients in the randomized, double-blind study across the U.S., Bulgaria, Georgia, Poland and the Czech Republic received either 266 mg of Exparel or placebo.
Patients recruited in Bulgaria and Georgia demonstrated a response favoring Exparel over placebo. But, this response was less marked in patients in Poland while patients recruited in the Czech Republic did not show this response.
The complete data set from the trial will be available in the next few weeks. Further analyses are currently underway to better understand why patients in some countries had positive results while others had high placebo response.
In May, Pacira reported positive findings from the Phase 2 portion of its other pivotal nerve block trial, a femoral nerve block study for total knee arthroplasty. Phase 3 portion of this study is ongoing.
The U.S. Food and Drug Administration indicated to the company at its End-of-Phase 2 Meeting that a single pivotal trial meeting its primary endpoint would be sufficient to gain approval for the nerve block indication, assuming demonstration of adequate safety.
Pacira plans to submit data from the ongoing femoral nerve block study to demonstrate efficacy and safety, as well as safety data from the intercostal nerve block study, for a supplemental New Drug Application expected early next year.
Dave Stack, CEO, said, "Given the FDA's position that a single positive pivotal trial would be sufficient for the approval of a nerve block indication and knowing that pain trials frequently fail to meet their primary endpoint, we had already planned two Phase 3 clinical trials as a risk mitigation strategy.''
The firm believes that with the positive interim results from the femoral nerve block study and the preliminary safety data from the intercostal block trial, it remains on track for submitting an sNDA next year.
PCRX closed up 0.5 percent on Thursday at $34.11, but fell 12 percent in the extended trade.
by RTT Staff Writer
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