Breaking News
FONT-SIZE Plus   Neg
Share SHARE
mail  E-MAIL

Pacira's Pain Drug Does Not Meet Primary Goal In Late-stage Study; Stock Down

RELATED NEWS
Trade PCRX now with 
8/2/2013 12:30 AM ET

Pacira Pharmaceuticals, Inc. (PCRX: Quote) 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.

Register
To receive FREE breaking news email alerts for Pacira Pharmaceuticals, Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Chipmaker Advanced Micro Devices Inc. said Thursday after the markets closed that its first quarter loss narrowed from last year, helped by strong revenue growth in its graphics and visual solutions business. The company's quarterly earnings per share, excluding items, also came in above analysts' expectations as did its quarterly revenue. After trending higher over the past few sessions, stocks showed a lack of direction throughout the trading day on Thursday. The major averages spent the session bouncing back and forth across the unchanged line before ending the day mixed. While the major averages closed on opposite sides of the unchanged line, they all showed only modest moves. U.S. Secretary Of State John Kerry said Thursday that he and his counterparts from Russia, Ukraine and the European Union have reached an agreement on a preliminary plan for ending the ongoing crisis in Ukraine. Kerry was speaking at the end of the Ukraine contact group's first meeting, comprising the foreign ministers of Russia, Ukraine, the EU and the U.S., in the Swiss city of Geneva.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.