Comments
yourfanat wrote: I am using another tool for Oracle developers - dbForge Studio for Oracle. This IDE has lots of usefull features, among them: oracle designer, code competion and formatter, query builder, debugger, profiler, erxport/import, reports and many others. The latest version supports Oracle 12C. More information here.
Cloud Expo on Google News
SYS-CON.TV

2008 West
DIAMOND SPONSOR:
Data Direct
SOA, WOA and Cloud Computing: The New Frontier for Data Services
PLATINUM SPONSORS:
Red Hat
The Opening of Virtualization
GOLD SPONSORS:
Appsense
User Environment Management – The Third Layer of the Desktop
Cordys
Cloud Computing for Business Agility
EMC
CMIS: A Multi-Vendor Proposal for a Service-Based Content Management Interoperability Standard
Freedom OSS
Practical SOA” Max Yankelevich
Intel
Architecting an Enterprise Service Router (ESR) – A Cost-Effective Way to Scale SOA Across the Enterprise
Sensedia
Return on Assests: Bringing Visibility to your SOA Strategy
Symantec
Managing Hybrid Endpoint Environments
VMWare
Game-Changing Technology for Enterprise Clouds and Applications
Click For 2008 West
Event Webcasts

2008 West
PLATINUM SPONSORS:
Appcelerator
Get ‘Rich’ Quick: Rapid Prototyping for RIA with ZERO Server Code
Keynote Systems
Designing for and Managing Performance in the New Frontier of Rich Internet Applications
GOLD SPONSORS:
ICEsoft
How Can AJAX Improve Homeland Security?
Isomorphic
Beyond Widgets: What a RIA Platform Should Offer
Oracle
REAs: Rich Enterprise Applications
Click For 2008 Event Webcasts
Mayo Clinic Proceedings Publishes Study of NUVIGIL in Patients with Shift Work Disorder

FRAZER, Pa., Nov. 2 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today announced that the November issue of Mayo Clinic Proceedings has published data from a pivotal Phase III trial demonstrating that NUVIGIL® (armodafinil) Tablets [C-IV] significantly improved wakefulness throughout the shift in patients with excessive sleepiness associated with shift work disorder (SWD). NUVIGIL, the longer-lasting isomer of modafinil, is indicated to improve wakefulness in patients with excessive sleepiness associated with shift work disorder, treated obstructive sleep apnea and narcolepsy. These data were part of the new drug application approved by the FDA in 2007.

This Phase III 12-week, randomized, double-blind, placebo-controlled study evaluated 254 permanent or rotating shift workers with shift work disorder at 42 sleep research centers in the United States and Canada. Study patients received NUVIGIL (150 mg) or a placebo at approximately one hour before each night shift. During weeks four, eight and 12, patients spent a night shift in the sleep laboratory, where investigators assessed patients' physiological propensity to fall sleep during night shift hours and clinicians' impression of disease severity, and patient-reported level of sleepiness.

The study showed that patients wakefulness significantly improved over the course of the trial in patients taking NUVIGIL (by 3.1 minutes) versus those on placebo (by 0.4 minutes) (P<0.001). This primary endpoint was evaluated by the Multiple Sleep Latency Test, which measured patients' time to fall asleep at specific times during the night shift.

"These findings are important, given that approximately 15 percent of U.S. employees work during nighttime hours and many may have symptoms of shift work disorder," said Thomas Roth, PhD, director of the Henry Ford Hospital Sleep Disorders and Research Center in Detroit and an investigator in the study. "The results establish the potential benefits of armodafinil (NUVIGIL) for patients with excessive sleepiness associated with shift work disorder."

Researchers also found that a significantly greater proportion of patients receiving NUVIGIL (79 percent) than placebo (59 percent) (P=0.001) improved, as evaluated by Clinical Global Impressions of Change (CGI-C), which measured overall wellbeing as related to sleepiness during night shifts including the commute to and from work. In addition, patients taking NUVIGIL showed improvement as measured by the Karolinska Sleepiness Scale (KSS), a patient-related subjective measure of sleepiness.

In this study, NUVIGIL was not found to affect daytime sleep, as measured by polysomnography (an objective measure of sleep), although two percent of patients reported insomnia. The most commonly reported adverse events in patients who received NUVIGIL were headache, nausea, nasopharyngitis (inflammation of the nasal passages and the upper throat) and anxiety.

ABOUT SHIFT WORK DISORDER

Shift work disorder is an important yet seldom recognized medical condition in which a person's internal clock, which helps regulate the cycle of sleeping and waking, is out of sync with his or her work schedule. The disorder is often triggered when people work outside of traditional work hours. Those affected by shift work disorder experience excessive sleepiness or insomnia to an extent that it is difficult for them to function effectively at work.

ABOUT NUVIGIL

NUVIGIL is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea, shift work sleep disorder, also known as shift work disorder (SWD) and narcolepsy. The NUVIGIL label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson syndrome, which has been reported in adults and children taking modafinil, a racemic mixture of S and R modafinil (the latter is armodafinil, the active ingredient in NUVIGIL). NUVIGIL is not approved for use in pediatric patients for any indication.

Patients should be advised that their level of wakefulness may not return to normal. Patients should be frequently reassessed for their degree of sleepiness and, if appropriate, advised to avoid driving or any other potentially dangerous activity.

Although NUVIGIL has not been shown to produce functional impairment, any drug affecting the central nervous system may alter judgment, thinking or motor skills. Patients should be cautioned about operating an automobile or other hazardous machinery until reasonably certain that NUVIGIL therapy will not adversely affect their ability to engage in such activities.

The most common adverse events in controlled clinical trials (five percent or greater) were headache, nausea, dizziness and insomnia. Full prescribing information for NUVIGIL is available at www.NUVIGIL.com.

ABOUT CEPHALON

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of many unique products in four core therapeutic areas: central nervous system, inflammatory diseases, pain and oncology. A member of the Fortune 1000 and the S&P 500 Index, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota.

Cephalon has a growing presence in Europe, the Middle East and Africa. The Cephalon European headquarters and pre-clinical development center are located in Maisons-Alfort, France, just outside of Paris. Key business units are located in England, Ireland, France, Germany, Italy, Spain, the Netherlands for the Benelux countries, and Poland for Eastern and Central European countries. Cephalon Europe markets more than 30 products in four areas: central nervous system, pain, primary care and oncology.

The company's proprietary products in the United States include: NUVIGIL, TREANDA(R) (bendamustine hydrochloride) for Injection, AMRIX(R) (cyclobenzaprine hydrochloride extended-release capsules), FENTORA(R) (fentanyl buccal tablet) [C-II], TRISENOX(R) (arsenic trioxide) injection, GABITRIL(R) (tiagabine hydrochloride), PROVIGIL(R) (modafinil) Tablets [C-IV], and ACTIQ(R) (oral transmucosal fentanyl citrate) (C-II). The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com/www.cephalon.com or by calling 1-800-896-5855.

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential pharmaceutical products, interpretation of clinical results, clinical development of NUVIGIL, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, sales and earnings guidance, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.

    Media:                                        Investors:
    Candace Steele Flippin                        Chip Merritt
    (610) 727-6231                                (610) 738-6376
    csteele@cephalon.com                          cmerritt@cephalon.com

SOURCE Cephalon, Inc.

About PR Newswire
Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest AJAXWorld RIA Stories
The standardization of container runtimes and images has sparked the creation of an almost overwhelming number of new open source projects that build on and otherwise work with these specifications. Of course, there's Kubernetes, which orchestrates and manages collections of cont...
Enterprises are striving to become digital businesses for differentiated innovation and customer-centricity. Traditionally, they focused on digitizing processes and paper workflow. To be a disruptor and compete against new players, they need to gain insight into business data and...
Digital Transformation: Preparing Cloud & IoT Security for the Age of Artificial Intelligence. As automation and artificial intelligence (AI) power solution development and delivery, many businesses need to build backend cloud capabilities. Well-poised organizations, marketing sm...
David Friend is the co-founder and CEO of Wasabi, the hot cloud storage company that delivers fast, low-cost, and reliable cloud storage. Prior to Wasabi, David co-founded Carbonite, one of the world's leading cloud backup companies. A successful tech entrepreneur for more than 3...
To Really Work for Enterprises, MultiCloud Adoption Requires Far Better and Inclusive Cloud Monitoring and Cost Management … But How? Overwhelmingly, even as enterprises have adopted cloud computing and are expanding to multi-cloud computing, IT leaders remain concerned about how...
Subscribe to the World's Most Powerful Newsletters
Subscribe to Our Rss Feeds & Get Your SYS-CON News Live!
Click to Add our RSS Feeds to the Service of Your Choice:
Google Reader or Homepage Add to My Yahoo! Subscribe with Bloglines Subscribe in NewsGator Online
myFeedster Add to My AOL Subscribe in Rojo Add 'Hugg' to Newsburst from CNET News.com Kinja Digest View Additional SYS-CON Feeds
Publish Your Article! Please send it to editorial(at)sys-con.com!

Advertise on this site! Contact advertising(at)sys-con.com! 201 802-3021


SYS-CON Featured Whitepapers
ADS BY GOOGLE