Navigation Links
Cephalon Announces Positive Results from a Phase Three Study of NUVIGIL in Jet Lag Disorder
Date:4/6/2009

Company to Submit a Supplemental New Drug Application to Expand the NUVIGIL(R) Label

FRAZER, Pa., April 6 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today announced positive results from a phase three clinical trial of NUVIGIL(R) (armodafinil) Tablets [C-IV] as a treatment for excessive sleepiness associated with jet lag disorder. Based on these findings, Cephalon(R) will file a supplemental New Drug Application with the U.S. Food and Drug Administration to expand the indications for NUVIGIL during the third quarter of this year.

The efficacy and safety of NUVIGIL as a potential treatment for acute excessive sleepiness associated with jet lag disorder were evaluated over the course of three days in a randomized, double-blind, placebo-controlled study of 427 healthy adults who had experienced jet lag symptoms during the previous five years. Participants in the study traveled eastbound from the United States to France where they were then examined at a sleep facility. Clinical efficacy was evaluated using two primary endpoints: an objective assessment -- the Multiple Sleep Latency Test (MSLT), and a subjective assessment -- the Patient Global Impression of Severity (PGI-S). Patients taking NUVIGIL (150 mg) showed a statistically significant improvement over placebo as measured by the MSLT [p<0.0001] and the PGI-S [p<0.05]. The results of this study will be submitted for presentation at a future medical meeting.

"After flying the subjects over the Atlantic, we objectively evaluated those receiving placebo versus those receiving NUVIGIL," said Dr. Lesley Russell, Chief Medical Officer and Executive Vice President at Cephalon. "We discovered that those on placebo were as excessivel
'/>"/>

SOURCE Cephalon, Inc.
Copyright©2009 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4

Related medicine technology :

1. Cephalon Announces Positive Results From a Phase Two Study of NUVIGIL in Bipolar Depression
2. Cephalon Signs Option Agreement to Acquire Ception Therapeutics
3. Cephalon Receives Complete Response Letter Regarding Request for Expanded FENTORA Label for Non-Cancer Breakthrough Pain
4. Journal of Clinical Oncology Publishes Study of Cephalon Medication TREANDA Plus Rituximab in Relapsed Non-Hodgkins Lymphoma
5. Cephalon Announces Positive Results from Its Pivotal Study of TREANDA in Patients with Non-Hodgkins Lymphoma
6. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
7. Cynosure Announces Presentation of Favorable Results from Post-Marketing Studies of Smartlipo MPX
8. Pharmaxis Announces Milestone in Phase III Trial for Cystic Fibrosis
9. Schering-Plough Announces Results of the Early ACS Trial
10. Hyperion Therapeutics Announces Results for Phase II Study in Urea Cycle Disorders
11. Lilly Announces Inconclusive Phase II Study Results for mGlu2/3 at the International Congress on Schizophrenia Research
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/23/2013)... 23, 2013 Amgen (NASDAQ: AMGN ) ... Healthcare Conference on Thursday, May 30, 2013, at the Westin ... 9:20 a.m. Eastern Daylight Time. Arvind Sood ... at the conference. Live audio of the presentation can be ... , under Investors. A replay of the webcast will also ...
(Date:5/23/2013)... 23, 2013  A recently published clinical study conducted ... Texas , demonstrates that 3D mammography (breast tomosynthesis) ... The study, "Implementation of Breast Tomosynthesis ... led by Stephen L. Rose , ... American Journal of Roentgenology (AJR). The AJR ...
(Date:5/23/2013)... 23, 2013 Anthem Blue Cross patients with ... required them to obtain their medications by mail order ... Whatley Kallas LLC.  The lawsuit, filed ... Blue Cross,s mandatory mail order program announced late last ... privacy. "This settlement brings to a close ...
Breaking Medicine Technology:First Large-Scale U.S. Study Validates the Benefits of 3D Mammography (Breast Tomosynthesis) Exams 2First Large-Scale U.S. Study Validates the Benefits of 3D Mammography (Breast Tomosynthesis) Exams 3Blue Cross To Allow HIV/AIDS Patients to "Opt-Out" of Mandatory Mail-Order Rx Drug Program, Announces Consumer Watchdog 2Blue Cross To Allow HIV/AIDS Patients to "Opt-Out" of Mandatory Mail-Order Rx Drug Program, Announces Consumer Watchdog 3
... Smith & Nephew Orthopaedics (NYSE: SNN ) ... French biotechnology company Graftys. The deal gives Smith & ... bone void filler in the U.S., and potentially in ... committed to offering our surgeon customers innovative solutions which ...
... 24, 2011 HealthWarehouse.com, Inc. (OTC: HEWA) a leading ... results for the first quarter ended March 31, 2011. ... the Company,s quarterly net sales increased $1,031,003 to $2,284,552, ... This growth was driven by strength in its prescription ...
Cached Medicine Technology:Smith & Nephew Signs Distribution Agreement for Unique Injectable Bone Void Filler With Graftys 2Smith & Nephew Signs Distribution Agreement for Unique Injectable Bone Void Filler With Graftys 3HealthWarehouse.com Reports 82% Quarter-Over-Quarter Revenue Growth in the First Quarter 2011 2
(Date:5/24/2013)... Denver, CO (PRWEB) May 24, 2013 ... SEO analysis, in partnership with JD Media Surge, a ... , The dental SEO analysis service will focus ... high in the search engines for their competitive keywords. ... the dentists website and recommendations based on what their ...
(Date:5/24/2013)... New York, New York (PRWEB) May 24, 2013 ... naturally white teeth. It is not uncommon for the majority ... natural teeth. Whether it is due to a coffee addiction ... this is why whitening procedures are so popular. ... of a new and very effective whitening system: Venus White ...
(Date:5/24/2013)... (PRWEB) May 24, 2013 Mr. Brian ... the 3rd Annual EB-5 Investment Summit: Dealmakers Conference in ... Conference will focus on exploring alternative finance through EB-5 ... market, legal and economic information, and updates to project ... the EB-5 industry. , "Our goal is to ...
(Date:5/24/2013)... (HealthDay News) -- People with high levels of cadmium ... of liver disease than those with lower levels, a ... in urine is evidence of long-term exposure to the ... tobacco smoke, the Johns Hopkins researchers explained. They ... directly causes liver disease but instead suggest an association ...
(Date:5/24/2013)... 2013 The Dictation Source recently added ... clients. As a result of its National marketing efforts, ... 20 states around the nation. , Since 1991, The ... to the healthcare industry . Dictation Source is owned ... years of clinical work experience to provide the solutions ...
Breaking Medicine News(10 mins):Health News:Dental SEO Analysis Launched by E-Dentists.com in Partnership with JD Media Surge 2Health News:Herald Square Dental Introduces New In-office Whitening System: Venus White Max 2Health News:Brian Su Organizes 3rd Annual EB-5 Investment Conference in Long Beach, California 2Health News:High Cadmium Levels May Raise Risk for Dying From Liver Disease: Study 2Health News:The Dictation Source Signs Two National Hospital Chains 2Health News:The Dictation Source Signs Two National Hospital Chains 3
... March 18 Askesis Development Group, Inc., a ... addictions treatment, and social services markets, is pleased ... and enhanced features are focused on creating a ... a comprehensive electronic medical record (EMR), and streamlined ...
... of certain cytokines spiked during disease stage , , WEDNESDAY, ... recently had the rare opportunity to follow the West ... in a 29-year-old lab worker who had accidentally jabbed ... researchers followed the trajectory of cytokines, a type of ...
... Institute of Technology are opening a new center that ... resonance imaging scanner to further study into the mysteries ... Advanced Brain Imaging, a joint venture of Georgia State ... topics from autism and learning disabilities, to applied physiology, ...
... disease recurrence, death nearly twice that of normal-weight patients ... cancer patients are more likely than non-obese patients to ... say U.S. researchers. , "We identified a subset ... at 12-fold increased risk of lymph node metastasis compared ...
... CEO until Executive Search for Replacement is CompletedPlanned ... 2009 at 4:15 PM ET LIVINGSTON, N.J., ... Board: MLSS), the recognized leader in advanced injection ... the Board, will temporarily assume the post of ...
... 18 The American Academy of Nurse Practitioners (AANP) ... position of AANP Chief Executive Officer, effective March 20, ... FAANP, who will retire after 13 years as CEO ... will continue in her role as Executive Director of ...
Cached Medicine News:Health News:Askesis Development Group, Inc. Launches New Behavioral Health Software for Electronic Medical Records (EMR) and Practice Management 2Health News:Course of West Nile Infection Charted 2Health News:Course of West Nile Infection Charted 3Health News:Georgia State/Georgia Tech Center for Advanced Brain Imaging to expand brain, mind research 2Health News:Obesity Tied to Poor Pancreatic Cancer Surgery Outcomes 2Health News:Milestone Scientific Announces Resignation of CEO 2Health News:Milestone Scientific Announces Resignation of CEO 3Health News:American Academy of Nurse Practitioners Announces New Chief Executive Officer 2
The Skull Pins are inserted into the receptacles of the Skull Clamp and fixate the head during surgery....
It is designed for rigid skeletal fixation. These pins are constructed of stainless steel and can be removed for sterilization and reuse....
Mayfield radiolucent skull clamp....
... for general applications and are equipped with our ... i.e. rigid endoscopes, range between 1 mm and ... to a 120 retrospection, and image angles ranging ... Endoscopes with working lengths of 1.5 meters and ...
Medicine Products: