New ETF Book by Larry Connors - Click here to read more
The randomized, double-blind, placebo-controlled study achieved its primary endpoints, demonstrating that sodium oxybate significantly decreased pain and fatigue, and improved daily function, in patients with fibromyalgia.
The 14-week study included 548 adult patients with fibromyalgia randomized to one of three treatment arms: sodium oxybate 4.5g/night, sodium oxybate 6g/night or placebo. The primary outcome measure, viewed by both US and EU regulatory authorities as a clinically meaningful endpoint, was the proportion of patients who achieved at least 30% reduction in pain from baseline to endpoint based on the pain visual analog scale.
In the top-line results, a significant number of patients treated with sodium oxybate achieved 30% or greater improvement in their pain compared to patients treated with placebo. Of those patients receiving sodium oxybate treatment, 46.2% of patients on 4.5g/night and 39.3% of patients on 6g/night reported this level of pain relief, compared with 27.3% of patients on placebo. These results were highly statistically significant.
Patients' physical functioning and ability to perform daily tasks, as measured by the FIQ, were significantly different from placebo for the 4.5g/night dose and approached significance for the 6g/night dose. Patients receiving sodium oxybate also reported significant improvement in fatigue, another common symptom of fibromyalgia, at both active dosage levels.
Only primary efficacy and safety data have been reviewed at this time. Further analyses will be undertaken to examine the full results, including secondary endpoints, in greater detail. The sodium oxybate Phase III clinical trial program also includes a second randomized, double blind, placebo-controlled study, which is continuing at sites in the US and Europe. More than 90% of the subjects have been enrolled in this second Phase III trial.
Jazz Pharmaceuticals anticipates submitting a new drug application for sodium oxybate to the FDA by the end of 2009. UCB anticipates filing in the EU shortly after. UCB has the exclusive marketing and distribution rights to sodium oxybate for fibromyalgia in Europe and some other countries outside North America and will manage registrations accordingly.
http://www.datamonitor.com
Republication or redistribution, including by framing or similar means, is expressly prohibited without prior written consent. Datamonitor shall not be liable for errors or delays in the content, or for any actions taken in reliance thereon
More News:
Market Updates |
Stock Alerts |
All Trading News |
Stock Index
About TradingMarkets | Contact | Advertise | Careers | Link to Us | Site Map | Help | Terms & Conditions | Privacy Policy | Return Policy | Testimonials | Feedback
The Connors Group, Inc. ("Company") is not an investment advisory service, nor a registered investment advisor or broker-dealer and does not purport to tell or suggest which securities or currencies customers should buy or sell for themselves. The analysts and employees or affiliates of Company may hold positions in the stocks, currencies or industries discussed here. You understand and acknowledge that there is a very high degree of risk involved in trading securities and/or currencies. The Company, the authors, the publisher, and all affiliates of Company assume no responsibility or liability for your trading and investment results. Factual statements on the Company's website, or in its publications, are made as of the date stated and are subject to change without notice.
It should not be assumed that the methods, techniques, or indicators presented in these products will be profitable or that they will not result in losses. Past results of any individual trader or trading system published by Company are not indicative of future returns by that trader or system, and are not indicative of future returns which be realized by you. In addition, the indicators, strategies, columns, articles and all other features of Company's products (collectively, the "Information") are provided for informational and educational purposes only and should not be construed as investment advice. Examples presented on Company's website are for educational purposes only. Such set-ups are not solicitations of any order to buy or sell. Accordingly, you should not rely solely on the Information in making any investment. Rather, you should use the Information only as a starting point for doing additional independent research in order to allow you to form your own opinion regarding investments. You should always check with your licensed financial advisor and tax advisor to determine the suitability of any investment.
HYPOTHETICAL OR SIMULATED PERFORMANCE RESULTS HAVE CERTAIN INHERENT LIMITATIONS. UNLIKE AN ACTUAL PERFORMANCE RECORD, SIMULATED RESULTS DO NOT REPRESENT ACTUAL TRADING AND MAY NOT BE IMPACTED BY BROKERAGE AND OTHER SLIPPAGE FEES. ALSO, SINCE THE TRADES HAVE NOT ACTUALLY BEEN EXECUTED, THE RESULTS MAY HAVE UNDER- OR OVER-COMPENSATED FOR THE IMPACT, IF ANY, OF CERTAIN MARKET FACTORS, SUCH AS LACK OF LIQUIDITY. SIMULATED TRADING PROGRAMS IN GENERAL ARE ALSO SUBJECT TO THE FACT THAT THEY ARE DESIGNED WITH THE BENEFIT OF HINDSIGHT. NO REPRESENTATION IS BEING MADE THAT ANY ACCOUNT WILL OR IS LIKELY TO ACHIEVE PROFITS OR LOSSES SIMILAR TO THOSE SHOWN.
The Connors Group, Inc.
15260 Ventura Blvd., Ste. 2200
Sherman Oaks, CA 91403
© Copyright 2009 The Connors Group, Inc.
