Navigation Links
FDA Approves Symbyax(R) as First Medication for Treatment-Resistant Depression
Date:3/23/2009

nclusive trial. The TRD-related label language includes efficacy data from three of these clinical studies (n=579). Acute safety information was based on a total of 10 studies. Doses evaluated in these studies ranged from 6-18 mg for olanzapine and 25-50 mg for fluoxetine in fixed combination.

  • An eight-week randomized, double-blind, controlled study was conducted to evaluate the efficacy of Symbyax in patients (n=300) who met the fourth edition of "Diagnostic and Statistical Manual of Mental Disorders" (DSM-IV) criteria for major depressive disorder (MDD) and did not respond to two antidepressants of adequate dose and duration in their current episode. Patients who were not responding to an antidepressant in their current episode entered an eight-week open-label fluoxetine lead-in, and then non-responders were randomized (1:1:1) to receive an eight-week trial of Symbyax, olanzapine, or fluoxetine. Symbyax was flexibly dosed between 6/50 mg, 12/50 mg, and 18/50 mg (olanzapine/fluoxetine dose). Results from this study yielded a greater statistically significant reduction in mean total Montgomery Asberg Depression Rating Scale (MADRS) scores from baseline to endpoint for Symbyax versus fluoxetine and olanzapine alone.
  • A second study of 28 patients who met the same criteria for TRD demonstrated statistically significant greater reductions in MADRS scores for Symbyax versus fluoxetine and olanzapine alone.
  • A third study demonstrated statistically significant greater reductions in total MADRS scores for Symbyax versus fluoxetine or olanzapine alone, when analyzed in a subpopulation of depressed patients (n=251) who met the same criteria for treatment resistance.
  • Although not cited in the approved label, two additional studies were included in the sNDA data package. One of the trials provided statistically significant supporting data for Symbyax in the acute treatment of TRD, while the other tri
    '/>"/>

SOURCE Eli Lilly and Company
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10

Related medicine news :

1. FDA Approves First Anti-Psychotic for Kids
2. FDA Approves New Roche West Nile Virus Blood Screening Test
3. FDA Approves Osteoporosis Drug to Cut Breast Cancer Risk
4. FDA Approves LEVAQUIN(R) Short-Course Therapy for Treatment of Complicated Urinary Tract Infections and Acute Pyelonephritis
5. FDA Approves SOMA(R) (carisoprodol) 250 mg
6. FDA Approves Expanded Label for FluMist(R) to Include Children Two to Five Years of Age
7. FDA approves expanded label for FluMist (influenza virus vaccine live, intranasal) to include childr
8. FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment for Leading Form of Adult Leukemia
9. ABIH Approves Certification Credit for SSPC Training Courses
10. FDA Approves REALIZE(TM) Adjustable Gastric Band for Morbid Obesity
11. FDA Approves New Flu Vaccine
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/25/2014)... Dennis Thompson HealthDay Reporter ... be closing in on a "fountain of youth" drug that ... of older adults, a new study suggests. Seniors received ... drug that targets a genetic signaling pathway linked to aging ... The experimental medication, a version of the ...
(Date:12/25/2014)... “ SmileStix ” was featured on NewsWatch as part of ... applications on the iOS, Android, and Windows markets. Andrew Tropeano, ... app review and shared with viewers how this is an ... saying goes, “A picture says a thousand words.” It’s true. ... single image, because each picture holds a unique and special ...
(Date:12/25/2014)... Each year trauma accounts for approximately ... admissions across the nation (according to the Centers ... National Hospital Ambulatory Medical Care Survey collected data ... 2010. They estimated that there were between 3.5 and ... primary diagnosis of broken bone or fracture. , ...
(Date:12/24/2014)... (PRWEB) December 25, 2014 Over 700 ... to their local communities. That is 700 smiling little ... single gift. Additionally over $6000 in monetary donations was ... offset some of the expenses they incur through the ... drive were A Child's Haven , Shrine's Children's ...
(Date:12/24/2014)... iFitDress.com, a famous dress manufacturer and retailer, has announced ... these items are brand new; they are made by experienced ... the new range of high quality prom gowns. A lot ... are made according to the latest trends. For years, the ... the company is handpicked by skilled tailors. , In the ...
Breaking Medicine News(10 mins):Health News:Researchers Take 'First Baby Step' Toward Anti-Aging Drug 2Health News:Researchers Take 'First Baby Step' Toward Anti-Aging Drug 3Health News:An Application to Create Custom Stickers was Featured on NewsWatch Television on December 19, 2014 2Health News:Every Year Four Million Emergency Department Visits Result from Accidents Involving Bone Trauma 2Health News:Every Year Four Million Emergency Department Visits Result from Accidents Involving Bone Trauma 3Health News:Every Year Four Million Emergency Department Visits Result from Accidents Involving Bone Trauma 4Health News:AlignLife Donates Over 700 Toys This Year 2Health News:Many Prom Dresses under 150 from Well-known Dress Manufacturer iFitDress.com 2
... FRANCISCO, Calif., June 1 Rigel Pharmaceuticals, Inc. (Nasdaq: ... Syk inhibitor, R788, is being evaluated in a Phase ... National Cancer Institute (NCI), part of the U.S. National ... will include patients with advanced colorectal, thyroid, non-small cell ...
... Company to Divest Late Stage Operations, Signs ... INC Research, , , TORONTO, June 1 /PRNewswire-FirstCall/ - ... leading provider of products and services to the global life ... MDS Pharma Services business on the delivery of Early Stage ...
... June 1 A panoramic downtown Milwaukee view, ... to the rooftop healing garden at Aurora St. ... and sounds awaiting guests at the newly opened ... Agnes and Morland Hamilton Healing Conservatory. , ...
... ... Contacts ( www.ClearlyContacts.ca ) and Stockhouse ( www.Stockhouse.com ), are pleased to announce the ... ... 2009 -- Two Vancouver based online powerhouses, Clearly Contacts ( www.ClearlyContacts.ca ) and Stockhouse ...
... , ... regulations have forced healthcare providers, insurers, and managed care organizations to take a hard look ... industry now changes. Instead of "Do I accommodate the LEP market?" we are asking, "How ... , ...
... Infants and young toddlers with obstructive sleep apnea and ... of the ailment, according to an invited article in ... Surgery . , The study evaluated 73 cases in ... for obstructive sleep apnea through the removal of the ...
Cached Medicine News:Health News:Rigel's R788 Evaluated in Phase 2 Trial in Multiple Cancers 2Health News:Rigel's R788 Evaluated in Phase 2 Trial in Multiple Cancers 3Health News:MDS Announces Strategy to Focus MDS Pharma Services on Early Stage Operations - Discovery Through Phase IIa 2Health News:MDS Announces Strategy to Focus MDS Pharma Services on Early Stage Operations - Discovery Through Phase IIa 3Health News:MDS Announces Strategy to Focus MDS Pharma Services on Early Stage Operations - Discovery Through Phase IIa 4Health News:Aurora St. Luke's Dedicates Rooftop Healing Garden and Conservatory 2Health News:Aurora St. Luke's Dedicates Rooftop Healing Garden and Conservatory 3Health News:Clearly Contacts Forms Strategic Marketing Alliance with Stockhouse 2Health News:Clearly Contacts Forms Strategic Marketing Alliance with Stockhouse 3Health News:Avantpage Translations Releases White Paper on Capturing The Fastest Growing Healthcare Market In America 2
(Date:12/22/2014)... and Markets ( http://www.researchandmarkets.com/research/h3xm6q/us ) has announced ... Market" report to their offering. ... focuses on the developments in the self-monitoring blood glucose ... Reimbursement analysis and the effects of competitive bidding have ... SMBG meters have been performed, based on the various ...
(Date:12/22/2014)... a privately-held medical products and technologies company, today announced ... Officer of the company, effective December 22, 2014. ... Board of Directors of ConvaTec thanks Mr. Berger for ... years," said Magnus Lundberg , the Chairman of ... company is well positioned for the future."  The company ...
(Date:12/22/2014)... /PRNewswire/ -- RXi Pharmaceuticals Corporation (NASDAQ: RXII ... and commercializing innovative therapies addressing major unmet medical ... open letter to shareholders from President & CEO, ... Dear RXi Shareholders, In the ... posted on certain social media sites seem to ...
Breaking Medicine Technology:US Self-monitoring Blood Glucose Market 2ConvaTec Names Paul Moraviec Interim CEO Effective December 22, 2014 2RXi Pharmaceuticals Issues Open Letter to Shareholders 2RXi Pharmaceuticals Issues Open Letter to Shareholders 3RXi Pharmaceuticals Issues Open Letter to Shareholders 4RXi Pharmaceuticals Issues Open Letter to Shareholders 5RXi Pharmaceuticals Issues Open Letter to Shareholders 6
... FORT LAUDERDALE, Fla., Nov. 27 Imaging,Diagnostic Systems, ... laser,optical breast imaging, announced today that the Company ... in its CTLM(R) clinical trials.,Under an approved protocol, ... submission of a Premarket Approval (PMA) application to ...
... 10:00 a.m. (EST), A World AIDS Day Call ... and African Women,s, Faith-based and Youth Rights,Organizations Call on Congress ... Plan, WASHINGTON, Nov. 26 The following was,released by ... November 29, 2007, at 10:00 a.m. EST, Who: ...
Cached Medicine Technology:Imaging Diagnostic Systems Updates PMA Filing Status for the New CT Laser Breast Imaging System 2Imaging Diagnostic Systems Updates PMA Filing Status for the New CT Laser Breast Imaging System 3World AIDS Day Audio Press Conference 2
9 mm blade....
Consist of 6 disposable bevel blades (N0522) and chuck handle (0521). Malleable shafts. Designated most popular model or size....
Duckbill. 3.5 mm tip. Light curve....
1.25 mm x 2.5 mm blade. 135 degrees back scratcher. Round handle....
Medicine Products: