Navigation Links
Indevus Announces Submission of New Drug Application
Date:8/28/2007

une 2007, reflecting the world-wide experience from over 260,000 injections of NEBIDO.

"The submission of the NEBIDO NDA is a very important milestone for the Company," said Glenn L. Cooper, M.D., chief executive officer and chairman of Indevus. "We strongly believe that NEBIDO can greatly improve the treatment options for men who suffer from hypogonadism."

Phase III Pharmacokinetic Trial

In June 2007, the Company announced positive results of its Phase III pharmacokinetic trial with NEBIDO. The purpose of the trial was to evaluate NEBIDO under U.S. Food and Drug Administration (FDA) pharmacokinetic guidelines for the approval of testosterone therapy products for male hypogonadism. The trial met its primary endpoints: a responder analysis based on the average testosterone concentrations during the steady-state dosing interval and an outlier analysis based on the maximum testosterone concentrations during the steady-state dosing interval.

Phase III Study Design

The Phase III pharmacokinetic trial was a randomized open-label (unblinded) study that included the evaluation of the pharmacokinetics of NEBIDO dosed as either 1000 mg every 12 weeks or as 750 mg every 12 weeks, both via intramuscular injection. The primary endpoints included a responder analysis (based on guidelines provided from the FDA for average testosterone concentrations over the steady state dosing interval) and an outlier analysis (based on the maximum testosterone concentrations during the steady state dosing interval). Specifically, a responder was defined (per the FDA) as a patient who, at steady-state conditions, had an average concentration of serum total testosterone (Cavg) within the normal range (300 to 1000 ng/dL). The primary response endpoint was met if at least 75% of patients achieved a Cavg within this normal range. FDA also provided guidelines related to maximum testosterone (Cmax) levels, including thresholds that no patient should exceed a testosterone c
'/>"/>

SOURCE Indevus Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Indevus Announces Presentation of Pagoclone Data at 47th Annual New Clinical Drug Evaluation Unit Meeting
2. Indevus Reports Positive Data From Phase III NEBIDO Trial
3. Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial
4. Sygnis Pharma AG announces date for presentation of clinical results
5. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
6. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
7. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
8. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
9. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
10. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
11. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/17/2014)... , September 17, 2014 According ... by Component (Sensor, Battery, Memory Device, Display, & Microprocessor/MCU), ... & Wellness), and by Geography - Global Forecast to ... electronics market is expected to reach $56.50 Billion by ... to 2020. Browse 235 market data Tables ...
(Date:9/17/2014)... -- Women everywhere know how frustrating a vaginal infection ... often also embarrassing and have a way of derailing ... http://ph-defense.com ) is a new, over-the-counter product designed to ... Odor, discharge, and discomfort or itch ... many cases, the cause of such problems can be ...
(Date:9/17/2014)... LEIPZIG, Germany , Sept. 17, ... has entered into an exclusive technology development partnership ... imaging agents to image CD4+ positive immune T ... ImaginAb,s capability to precisely diagnose and determine therapeutic ... areas. The ability to image CD4+ T-cells will ...
Breaking Medicine Technology:Medical Electronics Market Worth $56.50 Billion by 2020 2Medical Electronics Market Worth $56.50 Billion by 2020 3Medical Electronics Market Worth $56.50 Billion by 2020 4New Product from Vireo Systems: pH-D Feminine Health Support 2ImaginAb Expands ImmunoPET Pipeline to Include CD4+ T-Cell Imaging 2
... , , , ... service Contract Research Organization (CRO) founded in India, today announced the ... Application Suite (OLSAS) by going live with Oracle Siebel Clinical Trial ... , "We are excited to have the rollout of ...
... Aug. 5 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: ... a New Drug Submission (NDS) with the Therapeutic Products ... the antidepressant trazodone. , "We are pleased to file ... R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. ...
Cached Medicine Technology:SIRO Clinpharm Completes Successful Implementation of Oracle Life Sciences Application Suite 2Labopharm files New Drug Submission with Health Canada for novel antidepressant 2Labopharm files New Drug Submission with Health Canada for novel antidepressant 3
(Date:9/17/2014)... Recently, UWDress.com, an innovative company that provides many kinds ... released its 2014 empire waist evening dress ... big sale for these new and beautiful products. All ... from 15 to 65 percent off. , It ... to wear materials. Its elegant items include gold empire ...
(Date:9/17/2014)... 2014 According to Centers for ... an estimated 173,285 sports- and recreation-related traumatic brain injuries, ... a blood test may be available to help doctors ... recovery will take. , In March of this ... found a way to test blood for a protein ...
(Date:9/17/2014)... (PRWEB) September 17, 2014 According ... Drug Administration report titled “Adverse Events Associated with ... a Dermal Filler,” unapproved use of Expression, a ... resulted in adverse reactions including discoloration, lumps, bruising, ... with FDA approval for cosmetic use include ...
(Date:9/17/2014)... Final Cut Pro X plugin developers have ... Pixel Film Studios. , “ProBlue 5k is a compilation of ... to epic,” said Christina Austin, CEO of Pixel Film Studios. ... a definite game changer.” , ProBlue 5k is the ultimate ... filmmaker ! This footage compilation of over 100 anamorphic flares ...
(Date:9/17/2014)... struggle to distinguish between a business strategy and business plan, ... answer by reading Per Wickstrom’s latest blog post. , “The ... and a business strategy are both strategic – and what’s ... view it is that a business plan is part one, ... , According to the blog post, a business plan is ...
Breaking Medicine News(10 mins):Health News:2014 Empire Waist Evening Dress Collection Now Unveiled At UWDress.com 2Health News:Breakthrough blood test will improve concussion diagnoses, treatment 2Health News:Breakthrough blood test will improve concussion diagnoses, treatment 3Health News:Simon Ourian, Kim Kardashian's Cosmetic Surgeon, Warns About Illegal Use of Expression as a Dermal Filler 2Health News:A New Plugin Entitled ProBlue 5k Was Released Today from Pixel Film Studios Exclusively for Final Cut Pro X 2Health News:Per Wickstrom’s Latest Blog Explores the Difference Between a Business Plan and a Business Strategy 2
... the Eye ... Americans at Great Risk, PINELLAS PARK, Fla., Nov. 12 ... largely unaware of,the dangers that extended exposure to harmful ultraviolet (UV) ... England Eye Institute,and Transitions Optical, found that while nearly 80 percent ...
... November 12 Schlafender Hase GmbH,today released the ... The Text Verification Tool is a patent-protected ... print layout ("artwork") on the data,level - independent ... may be annotated, saved in PDF format and ...
... with prostate cancer are at greater risk of death after ... 2007 issue of CANCER, a peer-reviewed journal of the American ... Massachusetts General Hospital in Boston and colleagues, found that a ... diagnosis was an independent risk factor for prostate cancer-related death. ...
... We Are" (p. 42). "There was at,the end of 1968 ... For the Sixties were also the glory years of the ... writes former,NBC News anchor Tom Brokaw, in his forthcoming book, ... which Newsweek looks back at,one of the defining years of ...
... in Washington D.C., North Texas, Los Angeles, and ... Chicago, Effort latest in long K of C tradition ... ... distributed a total of $1 million worth of wheelchairs to veterans,in need at four locations on ...
... of the same,family, who owned and operated a ... Comprehensive Outpatient Rehabilitation Facilities have,each been sentenced to ... General Alice S. Fisher of the Criminal Division ... District of Florida announced today., Carlos Berenguer, ...
Cached Medicine News:Health News:Survey Confirms Americans Have a True 'Blind Spot' Regarding Their Eye Health - and the Real Danger of UV Rays 2Health News:Survey Confirms Americans Have a True 'Blind Spot' Regarding Their Eye Health - and the Real Danger of UV Rays 3Health News:Survey Confirms Americans Have a True 'Blind Spot' Regarding Their Eye Health - and the Real Danger of UV Rays 4Health News:Schlafender Hase Releases Text Verification Tool 4.0 2Health News:Obesity and overweight linked to higher prostate cancer mortality 2Health News:NEWSWEEK: Media Lead Sheet/November 19, 2007 Issue (on newsstands Monday, November 12) 2Health News:NEWSWEEK: Media Lead Sheet/November 19, 2007 Issue (on newsstands Monday, November 12) 3Health News:NEWSWEEK: Media Lead Sheet/November 19, 2007 Issue (on newsstands Monday, November 12) 4Health News:NEWSWEEK: Media Lead Sheet/November 19, 2007 Issue (on newsstands Monday, November 12) 5Health News:Knights Distribute $1 Million Worth of Wheelchairs to Veterans 2Health News:Four Miami Health Care Company Owners Sentenced to 57 Months in Prison For Medicare Fraud 2
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: