Shares of Javelin Pharmaceuticals tanked Tuesday morning after investors got wind of mixed Phase III data for its post-operative pain drug Ereska.
Its stock plunged 30 percent on the news that Ereska just barely missed hitting its primary goal of reduced pain following surgery. Secondary endpoints were achieved. The trial focused on the pain experienced by 259 patients for six hours following orthopedic surgery.
"The baseline- and site-adjusted means (plus or minus standard errors) for SPID-6 were 78.2 ± 12.4 for the Ereska group and 47.9 ± 12.3 for the placebo group, yielding a borderline P-value of 0.053," reported Javelin. "(The standard for statistical significance in pivotal clinical trials is a P-value of 0.05 or less.) Having had only a brief period of time to review select data from the trial, our initial assessment is that a high degree of intersubject variability likely impacted the P-value of the primary endpoint. In addition, certain clinically relevant secondary endpoints that we have been able to review so far, including patient global evaluations, were statistically significant in favor of Ereska."
- check out the Javelin release
- read the AP report