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:12/24/2014)... Dec. 23, 2014  Medical Science Liaisons play a ... link between the medical device industry and key stakeholders, ... the coming years as the device industry relies on ... to research by benchmarking firm, Best Practices, LLC, one ... important edge is by harnessing new technology to enable ...
    (Date:12/22/2014)... LAWRENCE, Mass. , Dec. 22, 2014 /PRNewswire/ ... a leading manufacturer of innovative dialysis products, announced ... (FDA) has cleared its System One™ to perform ... sleeping, known as home nocturnal hemodialysis. NxStage,s® System ... cleared by the FDA for this indication. ...
    (Date:12/22/2014)... 22, 2014 Research and Markets ( ... "US Self-monitoring Blood Glucose Market" report to their ... This market insight focuses on the developments in ... United States . Reimbursement analysis and the effects ... for more than 73 SMBG meters have been performed, ...
    Breaking Medicine Technology:Role of Medical Science Liaisons Evolving in Medical Device Sector 2NxStage Receives FDA Clearance for Home Nocturnal Hemodialysis 2NxStage Receives FDA Clearance for Home Nocturnal Hemodialysis 3US Self-monitoring Blood Glucose Market 2
    ... COLLEGEVILLE, Pa., and TARRYTOWN, N.Y., May 22 ... ), and Progenics,Pharmaceuticals, Inc. (Nasdaq: PGNX ), ... with investigational oral and,intravenous formulations of RELISTOR(TM) (methylnaltrexone ... phase 2 trial, evaluated the effects of,an oral ...
    ... LAS VEGAS, May 22 CardioVascular,BioTherapeutics, Inc. (OTC Bulletin ... Christopher Moore to be the sponsor and general,partner of ... of,$1 million and up to $10 million of the ... am extremely impressed with CVBT,s wound healing drug, which ...
    Cached Medicine Technology:Wyeth and Progenics Announce Preliminary Clinical Trial Results for RELISTOR Oral and Intravenous Formulations 2Wyeth and Progenics Announce Preliminary Clinical Trial Results for RELISTOR Oral and Intravenous Formulations 3Wyeth and Progenics Announce Preliminary Clinical Trial Results for RELISTOR Oral and Intravenous Formulations 4Wyeth and Progenics Announce Preliminary Clinical Trial Results for RELISTOR Oral and Intravenous Formulations 5Wyeth and Progenics Announce Preliminary Clinical Trial Results for RELISTOR Oral and Intravenous Formulations 6Wyeth and Progenics Announce Preliminary Clinical Trial Results for RELISTOR Oral and Intravenous Formulations 7Dr. Christopher Moore to Form ProDerm LP to Fund CVBT Wound Healing Trial 2Dr. Christopher Moore to Form ProDerm LP to Fund CVBT Wound Healing Trial 3
    (Date:12/25/2014)... The microscopy market is estimated to grow at ... by 2019. Optical microscopy is the largest segment ... segment is expected to show the fastest growth ... nanotechnology, technological advancements, and increasing federal support to ... Full Copy of Report @ http://www.marketsandmarkets.com/Market-Reports/world-microscopy-399.html ...
    (Date:12/25/2014)... New York, New York (PRWEB) December 25, 2014 ... of the 2010 DePuy ASR hip recall ( http://www.consumerinjurylawyers.com/DePuy/ ... Liebhard LLP reports. According to an Order issued in ... November 20th, the Court will convene an open conference ... Federal Building and United States Courthouse in West Palm ...
    (Date:12/25/2014)... Recently, BellasDress has launched its Christmas Sale, ... has chosen their best-selling lace wedding dresses, vintage bridesmaid ... season. , Now, BellasDress.com features popular women’s dresses, ... discount prices. The business hopes everyone can have a ... , “All our elegant products are made with exquisite ...
    (Date:12/25/2014)... HealthDay Reporter WEDNESDAY, Dec. ... chronic illnesses can receive effective, less expensive care from a ... to a team of dedicated health care professionals, a new ... ill and need either hospitalization or a trip to the ... home clinic at the University of Texas in Houston versus ...
    (Date:12/25/2014)... December 25, 2014 AngelWeddingDress.com tries its ... the online realm. Today, the business has introduced its ... site-wide prom dress promotion. , The new prom outfits ... and every dress lover. They are specially designed for ... prom dresses should visit its website before Jan. ...
    Breaking Medicine News(10 mins):Health News:Microscopy Market Hit to $5,756.0 Million by 2019 - New Research Report by MarketsandMarkets 2Health News:Microscopy Market Hit to $5,756.0 Million by 2019 - New Research Report by MarketsandMarkets 3Health News:Microscopy Market Hit to $5,756.0 Million by 2019 - New Research Report by MarketsandMarkets 4Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 2Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 3Health News:BellasDress.com’s Christmas Sale: Trendy Wedding Dresses With Big Discounts 2Health News:Coordinated Care Through 'Medical Home' Best for Chronically Ill Kids: Study 2Health News:Coordinated Care Through 'Medical Home' Best for Chronically Ill Kids: Study 3Health News:Angelweddingdress 2015 Prom Dresses Online Now 2
    ... , DETROIT, Sept. 21 Webahn, Inc. announces ... for its online Electronic Medical Records service Capzule.com and Accent, ... , , Capzule enables physicians to ... also has the capability to send messages, add notes, prescribe ...
    ... (DVT) is a serious condition that involves the formation of ... the legs. A patient with DVT is typically treated with ... radiology procedures may play a more central role in the ... the October issue of the American Journal of Roentgenology ...
    ... Bradley Cooper, Soleil Moon Frye, Terrell Owens, ... Pierce Strut Purple for Alzheimer,s Association , , ... new data released estimates 35 million people worldwide -- a 10% ... the urgent need for action and response. , , ...
    ... NEW ORLEANS, Sept. 20 Jack Mackenroth, from the ... the 20th annual NO/AIDS Walk and is bringing Living Positive ... the city. On Sunday, September 20th, Jack will participate in the ... as several other AIDS Service Organizations in Louisiana each year. The ...
    ... with advanced non-small-cell tumors, study finds, , SATURDAY, Sept. ... pemetrexed improves the survival of people with non-small-cell lung ... new study has found.</p, Nearly 90 percent of all ... At the time the cancer is discovered, it,s considered ...
    ... Lift ... collection of lift chairs and other mobility products. , ... Raleigh, NC (PRWEB) September 19, 2009 -- Lift Chairs 101, a leader in sales ... , offering a variety of styles and prices in order to better meet the mobility needs ...
    Cached Medicine News:Health News:Voice, Medical Records iPhone Apps Launched for Physicians 2Health News:Image-guided treatment for deep venous thrombosis could improve patients' long-term outcomes 2Health News:Celebrities Vie For 'Who Wears Purple Best?' Title to Raise Awareness of New Global Prevalence On World Alzheimer's Day 2Health News:Celebrities Vie For 'Who Wears Purple Best?' Title to Raise Awareness of New Global Prevalence On World Alzheimer's Day 3Health News:REPEAT: 'Project Runway' Designer in New Orleans to Educate About Living with HIV and Combat Stigma Associated with the Disease through Living Positive By Design 2Health News:REPEAT: 'Project Runway' Designer in New Orleans to Educate About Living with HIV and Combat Stigma Associated with the Disease through Living Positive By Design 3Health News:New Drug May Offer Hope to Some With Lung Cancer 2Health News:Lift Chairs 101 Introduces New Bathtub Lift Line 2
    Cloward cervical retractor. Size 18 mm....
    Large, removable blades, length 242 mm, (9 1/2"). Function: tissue retracting....
    Toothed Pituitary IVD Rongeurs, 8 length 200 mm....
    Suitable for children and adults. New mechanical design of the skull pin holder and the clamp base ensures improved rigid skull fixation....
    Medicine Products: