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Third Party Reexamination Of Javelin Pharmaceuticals' Phase III Trial Data For Ereska Yields Statistically Significant Primary Endpoint

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Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV - News) announced that a reexamination conducted by a third party of pain score measurements from its Phase III study of Ereska™ (intranasal ketamine) 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.
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 was the summary of pain intensity differences over a 6 hour period after initial drug dosing (SPID-6). The results for SPID-6 (means plus or minus standard errors), as determined by the third party biostatistics firm, were 78.5 12.4 for the Ereska group and 47.3 12.3 for the placebo group, yielding a P-value of 0.046. (The standard for statistical significance in pivotal clinical trials is a P-value of 0.05 or less.) The initially announced results released in August 2009, which the Company stated at that time would be thoroughly reexamined and could change, showed SPID-6 values of 78.2 12 for Ereska and 47.9 12.3 for placebo, yielding a P-value of 0.053.
"We continue to believe that Ereska is an attractive drug candidate. Thorough third-party reexamination of the first Ereska Phase III trial has demonstrated that Ereska can provide meaningful pain relief for patients with acute moderate to severe pain following a variety of major orthopedic surgical procedures," stated Dr. Daniel Carr, Javelin's President and Chief Medical Officer. "We will now move forward to meet with the FDA to discuss these trial results and the development path for Ereska."
About the Study
The study's primary measure of efficacy was the Sum of Pain Intensity Differences over 0-6 hours in patients who received Ereska 30 mg compared to those who received placebo (SPID-6). Pain intensity was recorded postoperatively just before treatment with Ereska or placebo. Pain intensity and pain relief were then recorded at 5, 10, 20, 30, 45 minutes and 1, 2, 3, 4, 5, and 6 hours after initiation of treatment.
Secondary measures of efficacy for the study included pain intensity differences (PID) at each scheduled evaluation time, pain relief at each scheduled evaluation time, the proportion of patients attaining meaningful (at least 30%) reduction in pain intensity, times to perceptible and meaningful pain relief, time to first administration of rescue medication and quantity of rescue medication consumed, and patient global evaluation of treatment.
About Ereska
Ketamine has been widely used for decades with well-recognized safety and effectiveness when given at high doses to induce and maintain general anesthesia. Javelin is developing Ereska, a proprietary formulation of ketamine, for intranasal delivery at doses well below those used for general anesthesia, as an analgesic for acute pain. Ketamine belongs to a nonopioid drug family known as NMDA receptor antagonists that show potential as analgesics when given alone or to augment analgesia from opioids such as morphine. Javelin believes that Ereska may offer a safe, non opioid alternative for the treatment of moderate-to-severe acute pain.
Prior randomized, double-blind, placebo-controlled, phase II clinical studies of Ereska have demonstrated rapid, statistically significant relief of moderate-to-severe acute postoperative pain after dental surgery and in cancer breakthrough pain. These study results have been published in peer-reviewed journals (Christensen et al, Acute Pain 2007; 9: 183-192; and Carr et al, Pain 2004; 108: 17-27), and presented at meetings of the American Society for Clinical Pharmacology and Therapeutics, the American Society of Clinical Oncology, and in a plenary session of the Advanced Technology Application for Combat Casualty Care. The U.S. Department of Defense has supported the development of Ereska as a fast-acting, noninvasive alternative to morphine for treatment of combat-related injuries.
On June 4, 2008, Javelin was awarded a patent in the European Union that extends patent protection for ERESKA into 2023. European Patent No. 1 562 566 B1, entitled: "Analgesic Compositions Comprising NMDA Receptor Antagonists and Benzalkonium Chloride," offers broad protection in the major EU market countries (G5) as well as in over twenty additional Member States of the European Patent Convention. This new patent is the European counterpart to Javelin's U.S. Patent No. 7,273,889 that issued in September, 2007.
Javelin Pharmaceuticals, Inc.
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