Pacira Pharmaceuticals' ($PCRX) drug Exparel failed to hit the primary endpoint in a Phase III clinical trial to reduce pain following major surgery. But the biotech company says it is remaining upbeat about its prospects at the FDA.
In the study, Exparel was designed to block intercostal nerves after posterolateral thoracotomy, a type of invasive surgery that involves an incision into the back to gain access to the heart, lungs, esophagus or other organs. The company announced Thursday that the study did not achieve its primary endpoint of a reduction of cumulative pain scores over 72 hours.
Pacira's shares were up slightly this morning.
In a study of 180 patients in the U.S., Bulgaria, Georgia, Poland and the Czech Republic, participants received either 266 mg of Exparel or placebo. Patients in Bulgaria and Georgia had a favorable response to Exparel over placebo, but this response was less pronounced in patients in Poland and was missing altogether in patients recruited in the Czech Republic. There were too few U.S. patients for that data to be meaningful.
The Parsippany, NJ-based company said it will continue to analyze the study outcomes to better understand why patients in some countries had positive results while others had a very high placebo response. Pacira said complete data will be available in the next few weeks.
In May 2013, Pacira reported positive findings from the Phase II portion of its other nerve block trial, a femoral nerve block study for knee joint surgery, and the Phase III portion is still ongoing. The FDA said if the company meets a primary endpoint in one of the trials, it would be enough to gain approval for the nerve block indication, according to the company. Pacira plans to submit a New Drug Application in early 2014 with safety data from the ongoing femoral nerve block study and intercostal nerve block study.