Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV - News) today described its initial review of top line results from a Phase III study of Ereska™ (intranasal ketamine 30mg). This randomized, multicenter, double-blind, 1:1 placebo-controlled study assessed the safety and analgesic efficacy of repeated doses of Ereska over 6 hours in 259 patients with acute moderate-to-severe pain following orthopedic surgery.
The predefined primary outcome measure for this trial was the summary of pain intensity differences over a 6 hour period after initial drug dosing (SPID-6). 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. (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.
Ereska was generally well tolerated in the trial. Of particular note, the incidences of psychological side effects were equal to or less than 3% in subjects given Ereska and were typically mild and transient.
The Company will thoroughly examine all aspects of this trial. In a recent interaction with the FDA, prior to the availability of this trial’s initial data, the Division offered to review the results of this study.
www.businesswire.com
Pharmaceutical Process Equipment
