Navigation Links
New Drug Application for Inhaled Treprostinil Submitted to the U.S. Food and Drug Administration
Date:6/30/2008

al benefit of an add-on therapy in PAH patients who are already receiving an approved background therapy. The study population consisted of 235 patients who were optimized on an approved oral therapy for PAH, either bosentan (Tracleer(R)), an endothelin receptor antagonist, or sildenafil (Revatio(R)), a phosphodiesterase-5 inhibitor. The majority of patients were New York Heart Association (NYHA) Class III (~98%) of varied etiologies, including idiopathic or familial PAH (~60%), collagen vascular disease associated PAH (~30%), and PAH associated with HIV, anorexigens or other associated conditions (~10%).

The primary efficacy endpoint of the TRIUMPH-1 clinical trial was the change in six-minute walk (6MW) distance at 12 weeks measured at peak exposure, defined by the trial protocol as 10-60 minutes after administration of ITRE relative to baseline. Analysis of the TRIUMPH-1 clinical trial results confirmed an improvement in median 6MW distance of approximately 20 meters (p<0.0005 at peak exposure, Hodges-Lehmann estimate and non-parametric analysis of covariance in accordance with the trial's pre-specified statistical analysis plan), in patients receiving ITRE as compared to patients receiving only background therapy. In addition, the 6MW distance at week 12 relative to baseline at trough exposure was also significantly improved, with an estimated treatment effect of approximately 14 meters (p<0.007). Secondary endpoints related to quality of life and change in NT pro-BNP, a plasma biomarker of cardiac function, were also significantly improved in the ITRE group as compared to the group receiving only background therapy (p<0.05). Other secondary efficacy measures, including change in Borg Dyspnea Score (shortness of breath test), NYHA functional class, signs and symptoms score, and time to clinical worsening, were not significantly different between the ITRE and background therapy only groups. Safety findings were typically those associated with the well-know
'/>"/>

SOURCE United Therapeutics Corporation
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. FDA Files Application To Convert ONTAK(R) (Denileukin Diftitox) to Full Approval for Use in Cutaneous T-Cell Lymphoma (CTCL)
2. Vermillion Files 510(k) Application With U.S. Food & Drug Administration for OVA1 Ovarian Tumor Triage Test
3. Synapse Biomedical Receives FDA Approval of NeuRx Diaphragm Pacing System (DPS)(TM) For Spinal Cord Injury Breathing Applications
4. Transcept Pharmaceuticals Announces Intent to Submit New Drug Application for Intermezzo(R) in Third Quarter 2008
5. Anesiva Announces South Korea FDA Approval of Adlea(TM) Investigational New Drug Application
6. Lilly Submits Cymbalta(R) Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration
7. GlaxoSmithKline Announces New Drug Application and Phase III Results for Rezonic(TM)/Zunrisa(TM) (Casopitant)
8. Community Breast Center Experience Shows Real-World Application of Breast-Specific Gamma Imaging Has Significant Impact on Clinical Care
9. European Regulatory Agency Accepts Cell Therapeutics, Inc.s Marketing Authorization Application for XYOTAX(TM) for Lung Cancer for Review
10. FDA Accepts Investigational New Drug Application for ARI-2243 and a First in Man Clinical Trial Set to Begin During the First Half of 2008
11. Cell Therapeutics, Inc. (CTI) Submits European Marketing Authorization Application for XYOTAX(TM)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/2/2015)... 2, 2015  OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ... announced today that members of its leadership team will ... including: , First World Congress on ... Food & Environmental Technologies; Portoroz, Slovenia ... Investment Conference; New York, NY ...
(Date:9/2/2015)... 2, 2015   Americord Registry , a private ... tissue banking company, announced today that is has earned ... Logo - http://photos.prnewswire.com/prnh/20150902/263095LOGO To ... grown at least tenfold over the past three years. Americord ... this trend with 50% quarterly growth during the first quarter ...
(Date:9/2/2015)... SHENZHEN, China, Sept. 2, 2015 China Nepstar ... the "Company"), a leading retail drugstore chain in China ... announced its unaudited financial results for the second quarter ... quarter ended June 30, 2015: , Revenue increased ... RMB686.6 million in the second quarter of 2014 ...
Breaking Medicine Technology:OncoSec to Present at Scientific and Investment Conferences in September 2OncoSec to Present at Scientific and Investment Conferences in September 3OncoSec to Present at Scientific and Investment Conferences in September 4OncoSec to Present at Scientific and Investment Conferences in September 5Americord Registry Announces Ranking on 2015 Inc. 500 2China Nepstar Chain Drugstore Ltd. Reports Second Quarter 2015 Financial Results 2China Nepstar Chain Drugstore Ltd. Reports Second Quarter 2015 Financial Results 3China Nepstar Chain Drugstore Ltd. Reports Second Quarter 2015 Financial Results 4China Nepstar Chain Drugstore Ltd. Reports Second Quarter 2015 Financial Results 5China Nepstar Chain Drugstore Ltd. Reports Second Quarter 2015 Financial Results 6China Nepstar Chain Drugstore Ltd. Reports Second Quarter 2015 Financial Results 7China Nepstar Chain Drugstore Ltd. Reports Second Quarter 2015 Financial Results 8China Nepstar Chain Drugstore Ltd. Reports Second Quarter 2015 Financial Results 9China Nepstar Chain Drugstore Ltd. Reports Second Quarter 2015 Financial Results 10
... 2011 The proposed combination of Express Scripts, Inc. ... Inc. (NYSE: MHS ) will bring clear ... purchasers, leading to safer, better and more affordable pharmaceutical ... state in testimony today before a House of Representatives ...
... 20, 2011 Virtual Radiologic (vRad) , ... initiative today to provide pro bono diagnostic radiology ... Without Borders/Medecins Sans Frontieres (MSF). Doctors ... assistance to people whose survival is threatened by ...
Cached Medicine Technology:Merger of Express Scripts and Medco Health Solutions Will Address the Bipartisan Mandate for Safer, More Affordable, Higher Quality Healthcare 2Merger of Express Scripts and Medco Health Solutions Will Address the Bipartisan Mandate for Safer, More Affordable, Higher Quality Healthcare 3Merger of Express Scripts and Medco Health Solutions Will Address the Bipartisan Mandate for Safer, More Affordable, Higher Quality Healthcare 4Merger of Express Scripts and Medco Health Solutions Will Address the Bipartisan Mandate for Safer, More Affordable, Higher Quality Healthcare 5Merger of Express Scripts and Medco Health Solutions Will Address the Bipartisan Mandate for Safer, More Affordable, Higher Quality Healthcare 6Merger of Express Scripts and Medco Health Solutions Will Address the Bipartisan Mandate for Safer, More Affordable, Higher Quality Healthcare 7Merger of Express Scripts and Medco Health Solutions Will Address the Bipartisan Mandate for Safer, More Affordable, Higher Quality Healthcare 8Merger of Express Scripts and Medco Health Solutions Will Address the Bipartisan Mandate for Safer, More Affordable, Higher Quality Healthcare 9Merger of Express Scripts and Medco Health Solutions Will Address the Bipartisan Mandate for Safer, More Affordable, Higher Quality Healthcare 10Merger of Express Scripts and Medco Health Solutions Will Address the Bipartisan Mandate for Safer, More Affordable, Higher Quality Healthcare 11Merger of Express Scripts and Medco Health Solutions Will Address the Bipartisan Mandate for Safer, More Affordable, Higher Quality Healthcare 12Merger of Express Scripts and Medco Health Solutions Will Address the Bipartisan Mandate for Safer, More Affordable, Higher Quality Healthcare 13Virtual Radiologic Partners with Doctors Without Borders/MSF to Deliver Expert Patient Care to Underserved Countries 2Virtual Radiologic Partners with Doctors Without Borders/MSF to Deliver Expert Patient Care to Underserved Countries 3
(Date:9/2/2015)... ... September 02, 2015 , ... Alameda County Community Food Bank ... Month” during the entire month of September. In the spirit of the ... efforts this September to an awareness campaign educating legislators and the public on ...
(Date:9/2/2015)... Norcross, GA (PRWEB) , ... September 02, 2015 ... ... Aflac Cancer Center at Children's Healthcare of Atlanta to help support ... C.H.O.A. to discuss the upcoming WSB Radio Care-A-Thon , which is the ...
(Date:9/2/2015)... Neb. (PRWEB) , ... September ... ... of the nation’s largest and fastest-growing interim clinical staffing companies, has completed ... and Heritage Group.         , BPOC and Heritage Group each offer ...
(Date:9/2/2015)... ... September 02, 2015 , ... Every year at this time, students prepare to ... are prepared to face the academic workload confronting them. They just don’t have the ... since schools don’t teach students how to study. , “Bankers bank. Salesmen sell. Teachers ...
(Date:9/2/2015)... Destin, Florida (PRWEB) , ... September 02, 2015 , ... ... in drug prices over the past year and its negative impact on consumers. It ... regular prescription medication and 10% were paying as much as an extra $100 compared ...
Breaking Medicine News(10 mins):Health News:#IfOnlyYouKnew: Alameda County Community Food Bank Commemorates September as National Hunger Action Month 2Health News:#IfOnlyYouKnew: Alameda County Community Food Bank Commemorates September as National Hunger Action Month 3Health News:#IfOnlyYouKnew: Alameda County Community Food Bank Commemorates September as National Hunger Action Month 4Health News:DoMyOwnPestControl.com Goes Gold for Childhood Cancer Awareness Month 2Health News:Medical Solutions Completes Recapitalization with Beecken Petty O’Keefe & Company and Heritage Group 2Health News:Medical Solutions Completes Recapitalization with Beecken Petty O’Keefe & Company and Heritage Group 3Health News:Medical Solutions Completes Recapitalization with Beecken Petty O’Keefe & Company and Heritage Group 4Health News:5 Essential Study Tips Every Student Needs for Academic Success but Schools Do Not Teach 2Health News:5 Essential Study Tips Every Student Needs for Academic Success but Schools Do Not Teach 3Health News:Watertree Health President Responds to Consumer Reports Survey on Rising Prescription Drug Prices 2
... sooner in unions where anger is suppressed , , FRIDAY, Feb. ... long marriage is communication, and new research now notes it,s ... study of Midwestern couples finds that those who felt free ... The couples with the most unexpressed anger died the earliest. ...
... will be the only one if its kind in ... Seattle Cancer Care Alliance (SCCA),and Northwest Hospital & Medical ... to explore the development of a new, state-of-the-art,cancer treatment ... announced its intention to develop a proton-therapy,facility in September ...
... WARSAW, Ind., Feb. 8 Symmetry Medical Inc.,(NYSE: ... the global,orthopedic device industry and other medical markets, today ... update press release on,February 14, 2008 before the opening ... accompanying conference call at 8:00 a.m. ET on,February 14, ...
... study of pregnant women, those with pregnancy-induced high blood ... peptide that raises blood pressure in the pieces of ... Wake Forest University Baptist Medical Center. The finding, reported ... the disorder develops. , Preeclampsia, or high blood pressure ...
... TSX: BMR, TORONTO, Feb. 8 /PRNewswire-FirstCall/ - ... development and,commercialization of cancer therapies, today announced that ... of the Company, will,participate as a presenter and ... Conference. Dr. Ezrin will provide an update on ...
... Mich., Feb. 8 Amigo Mobility, a,leading manufacturer ... ), a manufacturer of polyurethane tires and tire ... will be,featured as original equipment on the Amigo ... supply Amigo Mobility with,approximately 25,000 tires per year., ...
Cached Medicine News:Health News:Mutual Resentment in Marriage Can Be Deadly 2Health News:Mutual Resentment in Marriage Can Be Deadly 3Health News:Seattle Cancer Care Alliance and Northwest Hospital Sign Letter of Intent to Develop Proton Therapy Center for Cancer Treatment 2Health News:Seattle Cancer Care Alliance and Northwest Hospital Sign Letter of Intent to Develop Proton Therapy Center for Cancer Treatment 3Health News:Symmetry Medical to Provide Fourth Quarter 2007 General Business Update on February 14, 2008 2Health News:New finding may help explain development of preeclampsia 2Health News:Bradmer to present at the 10th Annual BIO CEO & Investor Conference 2Health News:Amigo Mobility Selects Amerityre as OEM Supplier 2Health News:Amigo Mobility Selects Amerityre as OEM Supplier 3
Stryker Endoscopy offers a superior selection of probes and tips that interface with our suction and irrigation system....
The new PERIMOUNT Magna heart valve (bioprosthesis), with its true supra-annular design, offers optimal hemodynamics and flow characteristics for treatment of aortic heart valve disease....
... revolutionary flexibility to floor-mounted X-ray systems. ... move the C-arm around the exam ... optimal angle for cardiac and general ... cardiac flat panel detector that delivers ...
... pH.p Capsule passes through the GI tract, it ... frequencies to the SmartPill Data Receiver, a small, ... the patient (supported by either a belt or ... and pH measurement data, and elapsed and real ...
Medicine Products: