Thursday, May 14, 2009 9:40:38 AM
""There's no possible way anyone knows if Ereska worked or not. Not til they unblind the data. But just remember, Ketamine has been used to treat pain successfully for 30 years and showed stellar results in phase 1 and phase 2 trials.
Here's some Ereska background
Previous randomized, double-blinded, placebo-controlled phase II clinical studies have demonstrated statistically significant (p<0.05) relief of moderate to severe post-operative and breakthrough pain. Ereska was fast-acting, with statistically significant (p<0.05) pain relief occurring as early as 4 minutes post administration of Ereska. Ereska also appeared to be safe and well-tolerated by patients. These results were presented at the American Society for Clinical Pharmacology and Therapeutics in Atlanta, Georgia in April 2002 and the American Society of Clinical Oncology in Orlando, Florida in May 2002. In May 2003, following the presentation of clinical data at the plenary session of the Advanced Technology Application for Combat Casualty Care conference in Orlando, Florida, the U.S. Department of Defense awarded a $4 million funding extension to Javelin to aid in the development of Ereska. This award is based on the need of the military for a fast-acting, non-invasive, and non-sedating alternative to the intravenous and oral medications commonly used for treatment of combat-related injuries. In June 2004, the company attended the End-of-Phase II meeting with representatives of the U.S. Food and Drug Administration (FDA). In August 2005, Javelin presented a meta-analysis of three randomized, placebo-controlled studies involving ketamine analgesia for patients with acute moderate-to-severe pain. The results of the meta-analysis demonstrated that intranasal ketamine was effective at relieving moderate-to-severe pain over the 10 to 50 mg dose range with no statistically significant changes to vital signs or arterial oxygen saturation levels. These data were presented at the Department of Defense’s premier medical conference, the Advanced Technology Application for Combat Casualty Care in St. Petersburg, Florida""
gbass
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