New book by Larry Connors Click here Improve your trading - See how
In a release, the Company noted:
Data from the studies, ALK33-003 and ALK33-004, showed that ALKS 33 was generally well tolerated and successfully blocked the effects of an opioid, with a duration of action that supports once daily dosing. Based on these results, Alkermes expects to initiate a phase 2 study of ALKS 33 by the end of calendar 2009.
"The data for ALKS 33 demonstrate our ability to develop new chemical entities based on our unique understanding of biological pathways and opioid pharmacology and sets the stage for the next phase of growth for our pipeline," said Elliot Ehrich, M.D., Chief Medical Officer at Alkermes. "We look forward to moving ALKS 33 into phase 2 development."
Trial Designs and Results
ALK33-003 was a phase 1 randomized, double-blind, placebo-controlled, multi-dose study designed to assess the steady-state pharmacokinetics, safety and tolerability of ALKS 33. Thirty healthy subjects were randomized to receive seven consecutive, daily oral doses of one of two dose levels of ALKS 33 or placebo. In the study, ALKS 33 demonstrated rapid oral absorption and sustained pharmacologically active plasma levels that support once daily dosing.
ALK33-004 was a phase 1, randomized, single-blind, placebo-controlled, single-dose study designed to test the ability of ALKS 33 to block the subjective and objective effects of a potent opioid agonist, remifentanil, a commercially available analgesic. Twenty-four healthy, non-dependent, opioid-experienced subjects were randomized to receive a placebo dose as well as one of two dose levels of ALKS 33, the same doses investigated in ALK33-003. Data showed that the onset of action of ALKS 33 was rapid and observed as early as 15 minutes following oral administration. A full blockade of the opioid agonist was observed and sustained for more than 24 hours following a single administration of ALKS 33. ALKS 33 was generally well tolerated in both studies.
Opioid receptor pathways have biological activity throughout the body including the brain, gastrointestinal system, immune system and cardiovascular system. Consequently, opioid receptor pathways play a key role in a broad range of nervous system disorders such as pain, addiction, psychiatric disorders, gastrointestinal disorders and immune disorders. Opioid modulators can act as agonists, antagonists or partial agonists at opioid receptors throughout the body. Emerging biological research and new medicinal chemistry insights now allow for the development of novel opioid modulators with the potential to show enhanced activity at opioid receptor sites and could ultimately lead to improved therapeutic options.
Alkermes, Inc. is a fully integrated biotechnology company committed to developing medicines to improve patients' lives. Alkermes developed, manufactures and commercializes Vivitrol for alcohol dependence and manufactures Risperdal Consta for schizophrenia and bipolar I disorder.
((Comments on this story may be sent to health@closeupmedia.com))
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.
10 Exchange Place, Suite 1800
Jersey City, NJ 07302
© Copyright 2009 The Connors Group, Inc.
