Navigation Links
Butrans® (Buprenorphine) Transdermal System CIII Pivotal Phase 3 Data Published in the Journal of Pain and Symptom Management
Date:10/26/2011

inimize opioid withdrawal symptoms in patients randomized to placebo.  Thereafter, the supplemental analgesia was limited to either acetaminophen 500 mg or ibuprofen 200 mg at a maximum of four tablets per day. Of the 257 patients randomized to Butrans, 9% discontinued due to lack of efficacy and 16% due to adverse events.  Of the 284 patients randomized to placebo, 13% discontinued due to lack of efficacy and 7% due to adverse events.  

Results were based on two study arms, Butrans (10 and 20 mcg/hour) and placebo, respectively.  The primary efficacy variable "average pain over the last 24 hours" score at Week 12 was statistically significantly lower for patients randomized to Butrans than for those randomized to placebo.  Sensitivity analyses of the primary efficacy variable and results of analyses of secondary efficacy variables supported the efficacy of Butrans relative to placebo.

In the Butrans group, gastrointestinal disorders, general disorders and administration site conditions, and nervous system disorders were the organ system classifications with the most commonly reported adverse events during the double-blind phase.  Adverse events reported in greater than or equal to 5% of patients during the open-label titration period and double-blind phase were nausea, dizziness, headache, application site pruritus, somnolence, vomiting, and constipation.  

Warnings and Precautions

  • Respiratory Depression: Respiratory depression is the chief hazard with Butrans.  Use with extreme caution in patients at risk of respiratory depression.
  • CNS Depression: Butrans may cause somnolence, dizziness, alterations in judgment and alterations in levels of consciousness, including coma.  Use with caution in patients who are receiving other central nervous system (CNS) depressants.  Additive CNS effects are expected when used with alcohol, benzodiazepines, other opioids, or
    '/>"/>

  • SOURCE Purdue Pharma L.P.
    Copyright©2010 PR Newswire.
    All rights reserved

    Page: 1 2 3 4 5 6

    Related medicine technology :

    1. Results of a Pivotal Phase 3 Efficacy and Safety Study for Butrans® (Buprenorphine) Transdermal System CIII Published in The Journal of Pain
    2. Purdue Pharma L.P. to Present Data From Clinical Program for Butrans™ (buprenorphine) Transdermal System CIII at PAINWeek® 2010
    3. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
    4. Phosphagenics to Conduct a Phase 1 Transdermal Oxycodone Clinical Trial
    5. Neupro(R) (Rotigotine Transdermal System) Effective in Controlling Early Morning Motor Impairment and Generally Well-Tolerated for Long-Term Use in Patients with Parkinsons Disease
    6. Rotigotine Transdermal System Shows Significant Symptom Reduction and Tolerability in Patients with Restless Legs Syndrome
    7. Long-Term 12-Month Safety Data Presented on ADHD Patch DAYTRANA(TM) (methylphenidate transdermal system)
    8. Echo Therapeutics Announces Positive Results with the Prelude(TM) SkinPrep System, the Next-Generation Skin Permeation Medium for its Symphony(TM) Transdermal Continuous Glucose Monitoring System
    9. New Analysis in Boys and Girls Shows the ADHD Patch, DAYTRANA(TM) (methylphenidate transdermal system), Offered ADHD Symptom Control for 12 Months
    10. Echo Therapeutics Initiates Clinical Study of Its Symphony(TM) Transdermal Continuous Glucose Monitoring System in Patients with Type 1 and Type 2 Diabetes
    11. Echo Therapeutics Announces Publication of Positive Clinical Data for its Symphony Transdermal Continuous Glucose Monitoring System in Journal of Diabetes Science and Technology
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:9/3/2015)... and REHOVOT, Israel, Sept. 3, 2015 OticPharma, ... developing innovative therapies for ear, nose, and throat (ENT) ... Newport Gateway office complex to be the location of ... move by end of September and will have office ... Headquarters: OticPharma, Inc. 19900 MacArthur Blvd., Suite ...
    (Date:9/2/2015)... NEW YORK , Sept. 2, 2015  The ... the future market of breast cancer drugs on the ... Breast cancer usually originates from the inner lining of ... This is a malignant type of tumor that can ... type of cancer which starts in lobules is referred ...
    (Date:9/2/2015)... LONDON , Sept. 2, 2015 ... Forecasts Summary Advanced dressings have steadily ... treatment of a variety of wound indications, such ... fluid management, infection control, and physical protection become ... a greater role in standard therapy. This ...
    Breaking Medicine Technology:OticPharma Establishes U.S. Headquarters in Orange County, California 2Breast Cancer Therapeutics: Pipeline Analysis Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2015 - 2023 2Breast Cancer Therapeutics: Pipeline Analysis Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2015 - 2023 3Advanced Wound Dressings - 5EU Analysis and Market Forecasts 2
    ... of Vermillion, Inc. (NASDAQ: VRML ), a leading ... successor to Gail S. Page, president and CEO. The board ... the search by September 2012. James S. Burns, ... led the divestiture of the company,s original research tools business, ...
    ...  InfuSystem Holdings, Inc. (NYSE MKT:  INFU), the leading national ... healthcare industry, today announced that it will release results ... 2012 following the market close.  The ... May 22, 2012 at 9:00 a.m. Eastern Time.  To ...
    Cached Medicine Technology:Vermillion Announces CEO Succession Plan 2Vermillion Announces CEO Succession Plan 3Vermillion Announces CEO Succession Plan 4
    (Date:9/3/2015)... ... September 03, 2015 , ... ... cost increases for fully insured employer-sponsored health insurance plans, more employers are moving ... according to data released from the 2014 United Benefit Advisors (UBA) Health Plan ...
    (Date:9/3/2015)... ... September 03, 2015 , ... DiabetesSisters Welcomes ... to announce the additional of Carol Wysham, MD, to their esteemed Board of ... Karczmarczyk, Donna Rice, David Warren, Matt Stella, Tricia Cedotal, Andrea Thomas, Wanda Nicholson ...
    (Date:9/3/2015)... ... September 03, 2015 , ... ... endpoint data collection, cloud analytics and workflow solutions today announced the complete ... Portugal, September 22-24, 2015. The esteemed faculty of worldwide pharmaceutical and industry ...
    (Date:9/3/2015)... (PRWEB) , ... September 03, 2015 , ... ... responsibility concierges; simplifying responsibilities which can impact the delicate life balance between work ... situation might be.” - Jeffrey R. Leaptrott, CEO , A LifeMinder Plus® Emergency ...
    (Date:9/3/2015)... NJ (PRWEB) , ... September 03, 2015 , ... ... today that AvePoint Perimeter Service Pack (SP) 4 – AvePoint’s solution for ... been named a “KMWorld 2015 Trend-Setting Product”. This is the fifth consecutive ...
    Breaking Medicine News(10 mins):Health News:Self-Funded Pharmacy Plans Becoming More Popular Among Large Employers 2Health News:Self-Funded Pharmacy Plans Becoming More Popular Among Large Employers 3Health News:Self-Funded Pharmacy Plans Becoming More Popular Among Large Employers 4Health News:Carol H. Wysham, MD, Joins DiabetesSisters Board of Directors 2Health News:ERT Announces Final Agenda, Faculty for European PRO / eCOA Congress 2Health News:ERT Announces Final Agenda, Faculty for European PRO / eCOA Congress 3Health News:LifeMinder Plus® Announces Emergency Care Document Set Giveaway for America 2Health News:LifeMinder Plus® Announces Emergency Care Document Set Giveaway for America 3Health News:AvePoint Perimeter Named a “KMWorld 2015 Trend-Setting Product” 2Health News:AvePoint Perimeter Named a “KMWorld 2015 Trend-Setting Product” 3Health News:AvePoint Perimeter Named a “KMWorld 2015 Trend-Setting Product” 4
    ... ... can help to prevent cavities. , ... Delray Beach, FL (PRWEB) July 8, 2009 -- Cavities are a persistent problem for ... to prevent them, according to Delray Beach, Florida-based dentist Dr. Craig Spodak, is to use ...
    ... 7 iMedX Inc., a leading healthcare software and services ... With this acquisition, iMedX expands its reach into the hospital ... companies in the United States. , , Based just ... systems across the country, utilizing a labor force of over ...
    ... OmniComm Systems, Inc. (OTC Bulletin Board: OMCM), a leader in ... today that its Board of Directors has retained Emerging Growth ... in evaluating strategic alternatives with a focus on acquisitions that ... believe that the scope of our product offerings and broad ...
    ... engineering David Bruce will participate in a multi-university Energy ... the U.S. Department of Energy. The Center for Atomic-Level ... new catalysts for the production of clean fuels and ... of CALCD, combined with those of 45 other new ...
    ... (Nasdaq: XTNT ) today announced that it has postponed ... at 9:00 a.m. Pacific Time on Thursday, July 9, 2009. ... August 3, 2009. , , On May 15, ... approved a Plan of Complete Liquidation and Dissolution of the Company ...
    ... (ZixCorp(R)), (Nasdaq: ZIXI ), the leader in hosted ... corporate update by its chief executive officer, Rick Spurr. , ... ZixCorp and we are on target to report within the ... are that we should meet our revenue guidance of $7.3 ...
    Cached Medicine News:Health News:South Florida Dentist Dr. Craig Spodak Recommends Artificial Sweetener Xylitol to Help Prevent Cavities 2Health News:iMedX Announces Acquisition of Medware Inc. 2Health News:OmniComm Systems, Inc. Retains Emerging Growth Equities, Ltd., as its Strategic Financial Advisor 2Health News:OmniComm Systems, Inc. Retains Emerging Growth Equities, Ltd., as its Strategic Financial Advisor 3Health News:DOE funds Clemson University clean energy research 2Health News:XTENT, Inc. Announces That It Has Postponed the Special Meeting of Its Stockholders 2Health News:Zix Corporation CEO Provides Corporate Update for Second Quarter 2009 2Health News:Zix Corporation CEO Provides Corporate Update for Second Quarter 2009 3Health News:Zix Corporation CEO Provides Corporate Update for Second Quarter 2009 4
    9 mm wide tip. 35 mm from angle to tip....
    Double-ended. 5 mm x 7 mm tips. Designated most popular model or size....
    Double-ended. 3 mm x 5 mm curette end and 3 mm spatula end....
    Double-ended. Semi sharp. Curved 3 mm tips. Angled right and left....
    Medicine Products: