Javelin Pharmaceuticals Inc (JAV)

[surf1944]

8:56AM Javelin Pharmaceutic says third party reexamination of its' Phase III trial data for Ereska yields statistically significant primary endpoint (JAV) 1.19 : Co announces that a reexamination conducted by a third party of pain score measurements from its Phase III study of Ereska showed that top line results for its primary endpoint were statistically significant. Previously, Javelin had reported that the top line results for its primary endpoint were not statistically significant. The previously disclosed top line results, based upon data captured by an external vendor, had inconsistencies whose presence was verified by a third party biostatistics company engaged by Javelin that thoroughly reexamined the trial's conduct and the initial primary analysis. The third party's correction of these inaccuracies yielded today's results. As previously disclosed, global patient satisfaction scores for Ereska were also statistically superior to placebo. All other secondary endpoints, while numerically superior to placebo, did not achieve statistical significance. Ereska, a nonopioid analgesic, was generally well tolerated in the trial. The Company plans to meet with the FDA to review the trial's results and discuss Ereska's registration program.