Navigation Links
Auxilium Pharmaceuticals, Inc. Announces Initiation of XIAFLEX® Phase III Studies for Peyronie's Disease
Date:10/11/2010

ients.  XIAFLEX will be administered two times a week every six weeks for up to four treatment cycles (2 x 4).  Each treatment cycle will be followed by a penile modeling procedure.  Patients will be followed for 52 weeks post-first injection in the double-blind studies and for 36 weeks in the open label trial.  

The trials' co-primary endpoints are the change from baseline in the Peyronie's disease bother domain of the Peyronie's Disease Questionnaire (PDQ) compared to placebo and percent improvement from baseline in penile curvature compared to placebo.  The PDQ will have at least three domains, which will include Peyronie's disease bother, severity of psychological and physical symptoms of Peyronie's disease, and penile pain.  Safety measurements will include adverse event monitoring, immunogenicity testing and clinical labs.

"We are encouraged by the clinical profile of XIAFLEX, which emerged from our earlier phase IIb clinical trial in Peyronie's disease.  XIAFLEX was well-tolerated and produced clinically significant reductions in both penile curvature and disease bother," said Dr. Jim Tursi, Auxilium's Vice President of Clinical Research & Development.  "Over the last six months, our team, in conjunction with the U.S. Food and Drug Administration (FDA), outside experts and men with Peyronie's disease, has spent a considerable amount of time and effort to refine the PDQ, which has now been accepted for use in the phase III clinical trials by the FDA's Study Endpoint and Label Development (SEALD) Division."

Conference Call and WebcastAuxilium will hold a webcast and conference call today, October 11, 2010 at 8:30 a.m. ET, to:

  • discuss the initiation of the global phase III program of XIAFLEX for the treatment of Peyronie's disease; and
  • update the leading indicators for the launch of XIAFLEX in Dupuytren's contracture.

  • The presentation slides to be used during the cal
    '/>"/>

    SOURCE Auxilium Pharmaceuticals, Inc.
    Copyright©2010 PR Newswire.
    All rights reserved

    Page: 1 2 3 4 5 6

    Related medicine technology :

    1. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
    2. Auxilium Pharmaceuticals, Inc. Announces XIAFLEX(TM) Meets Primary Endpoint With Statistical Significance (p<0.001) in CORD I Pivotal Phase III Study for Dupuytrens Contracture
    3. BioSpecifics Technologies Corp. Announces Auxilium XIAFLEX® Update
    4. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
    5. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
    6. Acura Pharmaceuticals, Inc. Secures Financing to Fund Pivotal Phase III Clinical Trial for Lead Aversion(R) Technology Product Candidate
    7. Sucampo Pharmaceuticals, Inc. Begins Pivotal Phase III Studies of Oral Lubiprostone to Treat Opioid-Induced Bowel Dysfunction (OBD)
    8. Symbollon Pharmaceuticals, Inc. Evaluates the Clinical Effects of IoGen(TM) on Fibrocystic Breast Disease
    9. Aegerion Pharmaceuticals, Inc. Presents Final Results of Phase II Clinical Trials for AEGR-733 at Drugs Affecting Lipid Metabolism (DALM) 2007 Conference
    10. Keryx Biopharmaceuticals, Inc. Announces Positive Preliminary Phase 2 Data on KRX-0401 in Patients with Chemo-Insensitive Rare Sarcoma
    11. Quark Pharmaceuticals, Inc. Announces First Systemic siRNA Dosing in Humans
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:9/20/2014)... issue: Mylan Pharmaceuticals ULC Canada, in consultation with Health Canada, ... mg/metered dose due to the product missing the "dip tube," ... A missing "dip tube" could pose a potential problem with ... lead patients to believe they are receiving the nitroglycerin, when ... nitroglycerin could place them at risk for either a delay ...
    (Date:9/19/2014)... , Sept. 19, 2014 Medical ... forging relationships with key opinion leaders (KOLs) who ... competition. Despite the critical nature of the MSL ... challenges, including altering the landscape for creating and ... According to research, the oversight responsibility for the ...
    (Date:9/19/2014)... Harwood Feffer LLP ( www.hfesq.com ) is ... PDL BioPharma, Inc. ("PDL" or the "Company") (Nasdaq: ... its fiduciary duties to shareholders or violated the federal ... Company disclosed: "On September 11, 2014, [PDL] was orally ... Young LLP ("EY"), that it was resigning effective September ...
    Breaking Medicine Technology:Advisory - Mylan Pharmaceuticals recalling nitroglycerin spray due to defective pump 2Role of Medical Science Liaisons Shifting in Healthcare Industry 2Harwood Feffer LLP Announces Investigation of PDL BioPharma, Inc. 2
    ... InspireMD, Inc. (OTC BB: NSPR) ("Inspire" or the ... commercialization of its proprietary stent platform technology, today announced that ... ended September 30, 2011 with the U.S. Securities and Exchange ... Year-to-Date Highlights Year-to-date shipment ...
    ... The new harder to crush version of OxyContin® has ... research revealed at a conference of law enforcement officers ... Prevention (CDC) announced that every day 100 people die ... prescription opioid pain relievers. A new formulation of the ...
    Cached Medicine Technology:InspireMD Reports Record Third Quarter 2011 Operating and Financial Results and Strategic Update 2InspireMD Reports Record Third Quarter 2011 Operating and Financial Results and Strategic Update 3InspireMD Reports Record Third Quarter 2011 Operating and Financial Results and Strategic Update 4InspireMD Reports Record Third Quarter 2011 Operating and Financial Results and Strategic Update 5InspireMD Reports Record Third Quarter 2011 Operating and Financial Results and Strategic Update 6InspireMD Reports Record Third Quarter 2011 Operating and Financial Results and Strategic Update 7InspireMD Reports Record Third Quarter 2011 Operating and Financial Results and Strategic Update 8InspireMD Reports Record Third Quarter 2011 Operating and Financial Results and Strategic Update 9New OxyContin® Has Lower Street Price Than Old Crushable Formulation 2
    (Date:9/20/2014)... Ticket Down is a reputable source ... popular ticket exchange is offering their customer appreciation promo code ... next step in the entertainment business. The 21-year-old from Boca ... and entertainment business, but is closing in on “Pop Diva” ... album, will hit the road next year on the “Honeymoon ...
    (Date:9/20/2014)... 2014 On Monday, September 22, Loma ... cancer research grant from Hyundai Hope on Wheels at ... Hospital located on 11234 Anderson St., in Loma Linda. ... Payne, Associate Professor at Loma Linda University and Director ... in children. , Loma Linda University Medical ...
    (Date:9/20/2014)... York, New York (PRWEB) September 20, 2014 ... filings continue to grow in federal court, Bernstein ... Food & Drug Administration (FDA) have voted overwhelmingly ... low testosterone in men be subjected to further ... According to a report published on September 18th ...
    (Date:9/20/2014)... 2014 The print component of ... of the Calgary Herald, with a circulation of ... 270,000. The digital component is distributed nationally through ... network of top news sites and partner outlets. ... visit http://www.worklifebalanceinfo.ca . , The publication features ...
    (Date:9/20/2014)... 20, 2014 Lifeinsurancequoteterm.net has released ... no medical exam life insurance plan provides for vulnerable ... family members should be a top priority for every ... insurance without taking medical examinations and visiting a doctor. ... medical examinations will provide coverage up to $300,000, but ...
    Breaking Medicine News(10 mins):Health News:Ariana Grande Tickets in Chicago/Rosemont, Kansas City, Milwaukee, Saint Paul, Dallas, Houston, San Antonio, Oklahoma City Go On Sale Today 2Health News:Ariana Grande Tickets in Chicago/Rosemont, Kansas City, Milwaukee, Saint Paul, Dallas, Houston, San Antonio, Oklahoma City Go On Sale Today 3Health News:Loma Linda University Medical Center Receives $250,000 Research Grant From Hyundai Hope On Wheels In Honor Of National Childhood Cancer Awareness Month 2Health News:Loma Linda University Medical Center Receives $250,000 Research Grant From Hyundai Hope On Wheels In Honor Of National Childhood Cancer Awareness Month 3Health News:As Testosterone Lawsuits Grow, Bernstein Liebhard LLP Notes Overwhelming Vote Calling for Further Study of Testosterone Heart Risks 2Health News:As Testosterone Lawsuits Grow, Bernstein Liebhard LLP Notes Overwhelming Vote Calling for Further Study of Testosterone Heart Risks 3Health News:Getting ‘Wellthy’: Mediaplanet’s “Work-Life Wellness” campaign puts stock in the personal and economic gains of healthy, vital workplace environments for Canadians 2Health News:No Medical Exam Life Insurance Provides Financial Protection for Families 2
    ... research led by a psychologist at the University of Georgia ... understanding of craving for alcohol and other drugs. This ... values a drug is fairly new, but according to the ... contribute to identifying more effective ways to defeat addictions. ...
    ... HealthDay Reporter , TUESDAY, July 13 (HealthDay News) ... survive the original cancer are at high risk of ... and stroke likely caused by the cancer treatment itself, ... cancer, many have long-term risks of dying prematurely from ...
    ... guidelines on recommended vitamin D intake have been published this ... Association Journal ( CMAJ ). Dr. David Hanley, ... member of Osteoporosis Canada,s (OC) Scientific Advisory Council, is the ... "OC,s current recommendations on vitamin D intake for Canadians ...
    ... By Amanda Gardner HealthDay Reporter , TUESDAY, ... the safety of controversial diabetes drug Avandia, members of the ... skeptical of much of the data presented. A decision ... The hearing has coincided with news that the drug,s ...
    ... regarding treatment following breast-conserving surgery for patients diagnosed with ... of discussion and confusion for patients and physicians alike. ... risk of local recurrence in the breast is high. ... treatment. While both treatments have been proven to ...
    ... protein already used to treat diseases like multiple sclerosis, hepatitis ... patients, UT Southwestern Medical Center researchers have found. ... of a population of immune cells known to cause asthma. ... called T helper 2 cells, or Th2 cells. Under normal ...
    Cached Medicine News:Health News:New analysis may help clarify the role of craving in addiction 2Health News:New analysis may help clarify the role of craving in addiction 3Health News:Childhood Cancer Survivors at Risk of Premature Death 2Health News:Childhood Cancer Survivors at Risk of Premature Death 3Health News:New vitamin D guidelines 2Health News:FDA Panel Seems Skeptical Over Key Avandia Data 2Health News:FDA Panel Seems Skeptical Over Key Avandia Data 3Health News:FDA Panel Seems Skeptical Over Key Avandia Data 4Health News:Prediction tool helps estimate local recurrence in patients with noninvasive breast cancer 2Health News:Prediction tool helps estimate local recurrence in patients with noninvasive breast cancer 3Health News:Interferon might help asthma patients breathe easier, UT Southwestern study suggests 2
    0.5% Yeast Extract, 2.0% Tryp, 10mM Sodium Chloride, 2.5mM Potassium Chloride, 10mM Magnesium Chloride, 10mM Mag. Sulfate....
    3.2% Tryptone, 2.0% Yeast Extract, 0.5% Sodium Chloride, pH 7.5....
    For use in implant arthroplasty associated with comminuted fractures, or rheumatoid, degenerative or post-traumatic disease of the radial head. Designed for higher demand patients requiring superior ...
    This legless table has adjustable height and round post. Pad sold separately....
    Medicine Products: