Pacira Pharmaceuticals, Inc. PCRX today announced data demonstrating
that EXPAREL^® (bupivacaine liposome injectable suspension) used in peripheral
nerve blocks has comparable safety to placebo and bupivacaine HCl. The
analysis, based on a review of six Phase 1-3 clinical trials, will be
presented during a podium session at the annual meeting of the American
Society of Anesthesiologists in New Orleans this week.
“Our review of this peripheral nerve block clinical program found that EXPAREL
administered at doses up to 266 mg as a femoral, intercostal or ankle block
exhibited a similar safety profile to both placebo and bupivacaine HCl,” said
Brian Ilfeld, M.D., the study's lead investigator and chair for clinical
research for the Division of Regional Anesthesia at the University of
California San Diego. “This safety profile involving peripheral nerve blocks
is similar to that found with wound infiltration and suggests that EXPAREL
will have the same safety success with peripheral nerve blocks as it has
exhibited for wound infiltration and hundreds-of-thousands of applications.”
The comparative analysis found that all groups experienced a similar rate of
adverse events (AEs) — 76% for EXPAREL vs 76% for placebo vs 61% for
bupivacaine HCl — and that these appeared to be related to the procedure or
opioid rescue rather than the study medication itself. The most common events
were in the gastrointestinal disorders class, followed by general
disorders/administration site conditions and nervous system disorders.
Additionally, the EXPAREL and placebo groups experienced a similar incidence
of:
* Serious AEs (8% for EXPAREL vs 10% for placebo); none of these were
assessed as being related to the study drug
* Nervous system AEs (21% in both groups)
* Cardiac AEs (9% vs 12%, respectively)
Older patients and patients with more co-morbidities were more prone to
experience adverse events, as expected, and this trend was true across all
groups.
“Building on the solid foundation of EXPAREL data that formed the basis of our
sNDA for an expanded nerve block indication, we are pleased to announce that
the first comprehensive review of our peripheral nerve block program
reinforces the safety profile of the product,” added Dave Stack, president,
chief executive officer and chairman of Pacira. “If approved for a nerve block
indication, we believe that EXPAREL could not only improve patient quality of
life by providing multiple days of postsurgical analgesia while eliminating
pumps and catheters, but also conserve hospital and provider resources
associated with the placement and management of continuous nerve blocks.”
EXPAREL is indicated for single-dose administration into the surgical site to
produce postsurgical analgesia. Pacira has submitted a supplemental New Drug
Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a nerve
block indication for EXPAREL, with a target Prescription Drug User Fee Act
(PDUFA) date of March 5, 2015.
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