Javelin Pharmaceuticals, Inc 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 six hours in 259 patients with acute moderate-to-severe pain following orthopaedic surgery.
The predefined primary outcome measure for this trial was the summary of pain intensity differences over a six 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 favour of Ereska.
Ereska was generally well toleratedin the trial. Of particular note, the incidences of psychological side effects were equal to or less than 3 per cent 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.
"Low, subaesthetic doses of ketamine are increasingly described by pain specialists as a useful alternative for pain control. The present trial provides additional valuable experience with intranasal ketamine for pain control. My colleagues and I will carefully review this data and the results of our earlier trials of Ereska as we proceed with the development of this novel product candidate," stated Javelin's chief medical officer, Daniel B Carr, MD.
Ketamine has been widely used for decades with well-recognized safety and effectiveness when given at high doses to induce and maintain general anaesthesia.
With corporate headquarters in Cambridge, Javelin applies innovative proprietary technologies to develop new drugs and improved formulations of existing drugs to target unmet and underserved medical needs in the acute pain management market.