Javelin Provides Top Line Results From Phase III Study Of Ereska

Javelin Pharmaceuticals (Javelin) has provided top line results from a phase III randomized, multicenter, double-blind, 1:1 placebo-controlled study of Ereska (intranasal ketamine 30mg).

The 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 orthopedic 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).

Ereska was generally well tolerated in the trial, said the company. 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 said that it will thoroughly examine all aspects of the trial. In a recent interaction with FDA, prior to the availability of this trial’s initial data, the division offered to review the results of this study.

Daniel Carr, CMO at Javelin, said: “Low, subanesthetic 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.”