|EXPAREL Use in Femoral Nerve Block for Total Knee Arthroplasty; NOXXON Presents Positive Results from Emapticap Pegol Nephropathy Study|
|By Staff and Wire Reports|
|Friday, 04 April 2014 19:32|
Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced additional Phase 3 data supporting the efficacy and safety of EXPAREL® (bupivacaine liposome injectable suspension) to achieve a femoral nerve block in patients undergoing total knee arthroplasty. The Company previously announced results of the primary efficacy endpoint, a statistically significant reduction in cumulative pain scores over 72 hours compared to placebo (P<0.0001). Secondary endpoints presented at the 39th Annual Meeting of the American Society of Regional Anesthesia and Pain Medicine (ASRA) found that a higher percentage of patients who received EXPAREL were pain-free, consumed fewer opioids and reported higher satisfaction with their pain control.
This randomized, double blind, placebo controlled study evaluated 278 patients who received either a femoral nerve block with EXPAREL or a placebo. A femoral nerve block provides pain control for the anterior (front) of the knee; in this trial there was no pain medication provided at the time of surgery for the posterior (back) of the knee, which explains the lack of a significant difference in time to first opioid rescue between the two study groups. In addition to pain scores through 72 hours, investigators also measured total opioid consumption through 72 hours, time to first opioid rescue, patient satisfaction with pain control and safety.
The key findings are summarized below:
NOXXON Pharma AG announced that Phase IIa proof-of-concept data from the emapticap pegol (NOX-E36) trial in diabetic nephropathy were presented at the ISN Nexus Symposium in Bergamo, Italy earlier today.
Emapticap pegol is a Spiegelmer® that binds and neutralizes CCL2/MCP-1 (C-C Chemokine Ligand / Monocyte Chemoattractant Protein-1), a pro-inflammatory chemokine that plays an important role in diabetic kidney disease, the most common single cause of chronic kidney failure and end-stage renal disease.
The objective of this randomized, double-blind placebo-controlled multi-center international study was to evaluate the efficacy, pharmacokinetics, safety and tolerability of treatment with emapticap pegol. Seventy-five type 2 diabetic patients with albuminuria on current standard of care to control hypertension, hyperglycemia and dyslipidemia were treated for 12 weeks with twice-weekly subcutaneous emapticap pegol or placebo. This treatment period was followed by a 12 week observational period to study the long-term effect of emapticap pegol treatment on albuminuria. Importantly, the underlying standard of care mandatorily included stable renin-angiotensin system (RAS) blockade, which has been demonstrated to reduce albuminuria and to slow progression of diabetic nephropathy. Emapticap pegol was found to be safe and well tolerated with no treatment-related serious adverse events. For the primary efficacy analysis, patients with major protocol violations, on dual RAS blockade, or with concomitant hematuria and leukocyturia were excluded.
Results showed relevant, statistically significant reductions in urinary albumin excretion and improved glycemic control. Importantly, these effects were independent of hemodynamic changes and maintained after cessation of treatment, suggesting that emapticap pegol interferes with the underlying pathophysiology of diabetic nephropathy. Long-lasting effects on urinary albumin after cessation of treatment are not seen with agents currently approved to treat diabetic nephropathy (ACE inhibitors and ARBs1) or with other agents that act primarily via a hemodynamic mechanism of action such as endothelin A receptor antagonists.
Professor Dr. Hermann Haller, Director of the Department of Nephrology and Hypertension at Hannover Medical School and lead investigator of the study commented: “This Phase IIa study clearly shows that emapticap pegol is exceptionally safe and well tolerated in the target population and produces significant and clinically relevant beneficial effects on albuminuria and glycemic control after only three months of treatment. The observation that these effects are maintained even after cessation of treatment suggests that emapticap pegol interferes with the underlying pathophysiology and may be the first disease-modifying drug for this indication.”
Dr. George Bakris, Professor of Medicine and Director of the ASH Comprehensive Hypertension Center at the University of Chicago Medicine remarked: “From the data I’ve seen, I’m particularly impressed by the dissociation of emapticap pegol’s albuminuria lowering effect from hemodynamics. The fact that this beneficial effect is accompanied by an additional benefit on glycemic control is a unique feature that differentiates this drug from other compounds in development.”
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