Healthcare Industry News: ketorolac tromethamine
News Release - September 12, 2006
Javelin Pharmaceuticals, Inc. To Present Final Analysis of Phase 2b Study Results of Dyloject(TM) at Prestigious European Pain Conference - September 14, 2006Cambridge, Mass., September 12, 2006 --(HSMN NewsFeed)--Javelin Pharmaceuticals, Inc. (Amex:JAV ), today announced that Daniel B. Carr, MD, Chief Executive Officer and Chief Medical Officer, will present the final results from Company's Phase 2b (DFC-002) study of Dyloject during a poster session at the 5th Congress of The European Federation of International Association for the study of Pain Chapters. The presentation is scheduled for September 14, 2006 from 16:00 p.m. to 16:45 p.m. EEST at the Istanbul Convention & Exhibition Centre (ICEC) Harbiye 80230 Istanbul, Turkey.
A total of 353 postsurgical patients from the United States were randomized in this multi-center, double-blind, placebo- and comparator-controlled study. Each patient received a single bolus intravenous injection of Dyloject(TM), IV ketorolac tromethamine or placebo. After dosing, patients were observed up to 24 hours post dose and returned to the clinic for a follow-up safety visit 5-9 days post dosing. In this "blinded" study, patients received treatments whose identity was not known by either the Investigator or the patient.
Dyloject(TM) - The Company's proprietary injectable formulation diclofenac sodium - is currently in Phase III development in the US for the treatment of acute moderate-to-severe pain. Javelin has filed a Marketing Authorization Application (MAA), presently under evaluation, to sell Dyloject in Europe. Earlier studies demonstrated Dyloject to be safe and well tolerated (including evidence for a lower incidence and severity of vein irritation than Voltarol, the currently marketed European formulation of injectable diclofenac). Prior studies have shown Dyloject to have a more rapid onset of action than Voltarol when both drugs were evaluated in patients with moderate-to-severe postoperative pain.
Diclofenac, is the most widely prescribed NSAID in the world. By the mid-1980s, it had already approached a level of exposure estimated in two independent safety reviews as 150 million patient-months. Subsequent sales figures suggest that its current safety database may now be closer to one billion patient-months. The clinical trial literature provides strong evidence that diclofenac given as an injection, tablet or suppository is effective against acute postsurgical pain. Oral diclofenac is also given for recurrent or chronic conditions such as migraine or arthritis. Diclofenac, unlike ibuprofen, does not interfere with the therapeutically desirable antiplatelet effect of low doses of aspirin. Unlike aspirin, diclofenac does not interfere with platelets in a prolonged fashion.
With corporate headquarters in Cambridge, MA, Javelin applies innovative proprietary technologies to develop new drugs and improved formulations of existing drugs to target unmet and underserved medical needs in the pain management market. The Company has two drug candidates in Phase III clinical development and one in late Phase II. One of these Phase III drug candidates, Dyloject(TM), is currently under review for Marketing Authorization Application (MAA) approval in Europe. Previous clinical trials have demonstrated its safety and rapid onset of action. For additional information about Javelin, please visit the company's website at http://www.javelinpharmaceuticals.com or contact us directly.
Forward Looking Statement:
This news release contains forward-looking statements. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other governmental regulation, our ability to obtain working capital, our ability to successfully develop and commercialize drug candidates, and competition from other pharmaceutical companies.
Source: Javelin Pharmaceuticals
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