Pacira Pharmaceuticals, Inc. PCRX today announced results from its
second pivotal, Phase 3 clinical trial assessing the safety and efficacy of
EXPAREL^® (bupivacaine liposome injectable suspension) in intercostal nerve
block for posterolateral thoracotomy. The study did not achieve its primary
endpoint of a reduction of cumulative pain scores over 72 hours.
The 180 patients in this 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 pronounced
in patients in Poland and missing in patients recruited in the Czech Republic
(there were too few U.S. patients in the study to be meaningful). The complete
data set from the trial will be available in the next few weeks, and further
analyses are currently underway to better understand why patients in some
countries had positive results while others had a very high placebo response.
In May 2013, 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; the Phase 3 portion of this study is ongoing. The U.S. Food and
Drug Administration (FDA) 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 (sNDA) anticipated in early 2014.
Market News and Data brought to you by Benzinga APIs© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in