Navigation Links
Vanda Announces Phase IIb/III Clinical Study In Major Depressive Disorder Did Not Meet The Primary Endpoint
Date:1/31/2013

WASHINGTON, Jan. 31, 2013 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) today announced top-line results of the Phase IIb/III clinical study (MAGELLAN) in Major Depressive Disorder (MDD), investigating the efficacy and safety of tasimelteon as a monotherapy in the treatment of patients with MDD.  The clinical study did not meet the primary endpoint of change from baseline in the Hamilton Depression Scale (HAMD-17) after 8 weeks of treatment as compared to placebo.  Both tasimelteon and placebo treated patients had an approximately 40% reduction of their MDD symptoms from baseline.  Tasimelteon was shown to be safe and well-tolerated, consistent with observations in prior studies.  Given these current proof of concept clinical study results, Vanda has decided to discontinue all activities in this indication.

"These results are disappointing, as there is still a significant unmet medical need for patients with Major Depression," said Mihael H. Polymeropoulos , M.D., President and CEO of Vanda.  "Tasimelteon's application in the treatment of blind individuals with Non-24 remains our top priority as we pursue our planned NDA submission this year."     

Vanda has recently reported positive results in two phase III clinical studies of tasimelteon in Non-24-Hour Disorder (Non-24) and plans to submit a New Drug Application to the U.S. Food and Drug Administration in mid-2013.

About MAGELLAN

MAGELLAN was a proof of concept, two arm (tasimelteon 20mg and placebo), 8-week, double-masked, randomized, phase IIb/III clinical study in patients with MDD.  The study enrolled 507 patients in 43 sites in the U.S.  The primary endpoint of the study was the change from baseline in the Hamilton Depression Scale (HAMD-17) at week 8. 


'/>"/>
SOURCE Vanda Pharmaceuticals Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Vanda Pharmaceuticals Reports First Quarter 2012 Results
2. Vanda Pharmaceuticals Inc. Presents Scientific Posters at Society for Research on Biological Rhythms (SRBR) Annual Meeting
3. Vanda Pharmaceuticals to Present at the Jefferies 2012 Global Healthcare Conference
4. Vanda Pharmaceuticals Announces Date of Annual Meeting of Stockholders
5. Michael Cola Joins the Board of Directors of Vanda Pharmaceuticals
6. Vanda Pharmaceuticals to Present at the JMP Securities Healthcare Conference
7. Vanda Pharmaceuticals to Announce Second Quarter 2012 Financial Results on August 2, 2012
8. Vanda Pharmaceuticals to Participate in Two September Healthcare Investor Conferences
9. Vanda Pharmaceuticals Reports Third Quarter 2012 Results
10. Vanda Pharmaceuticals to Announce Fourth Quarter 2012 Financial Results on February 12, 2013
11. Vanda Announces Positive Results in the Second Phase III Study (RESET) of Tasimelteon for the Treatment of Non-24-Hour Disorder
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/22/2014)... Calif. , Dec. 22, 2014 Apnea ... expanded corporate offices in Aliso Viejo ... that due to the tremendous growth and worldwide expansion, ... Sales of patented SnoreRx, the anti snore cure have ... He said, "We are now in 23 countries ...
(Date:12/22/2014)... , Dec. 22, 2014   TRU-D SmartUVC ... UV disinfection robot, announced today that the General Services ... through November 2019.   This newly formed ... all levels of government purchasers, including Department of Veteran ... as Homeland Security contacts purchasing solutions for the Ebola ...
(Date:12/22/2014)... , Dec. 22, 2014  ConvaTec, a privately-held medical ... has been appointed Interim Chief Executive Officer of the ... succeeds Ken Berger .  "The Board of Directors ... leading ConvaTec over the past three years," said ... Directors.  "We are confident that the company is well ...
Breaking Medicine Technology:TRU-D SmartUVC LLC Awarded General Services Administration Contract to Expand Government Customer Base 2ConvaTec Names Paul Moraviec Interim CEO Effective December 22, 2014 2
... Pharmasset, Inc. (Nasdaq: VRUS ) announces that ... held May 2 to 4, 2011 at the InterContinental Hotel, ... Healthcare Conference being held May 10 to 12, 2011, at ... President and Chief Executive Officer, will provide an overview of ...
... April 28, 2011 Biodesix announces the enrollment of ... Addario Lung Cancer Medical Institute (ALCMI, pronounced as "Alchemy"). ... is recruiting a minimum of 250 subjects over two ... United States. The study collects biospecimens and data from ...
Cached Medicine Technology:Pharmasset to Present at Two Upcoming Investor Conferences 2Pharmasset to Present at Two Upcoming Investor Conferences 3Biodesix Supports Unique Lung Cancer Research Initiative 2Biodesix Supports Unique Lung Cancer Research Initiative 3
(Date:12/26/2014)... 2014 Parker & Sons, Inc. ... in heating, cooling and plumbing contractor services throughout ... services in 2014 with regard to air-conditioning systems. ... is known for its incredibly hot summers. Working ... intricacies and details of a wide variety of ...
(Date:12/25/2014)... 2014 The click strand ... strength and durability. Today, the business announces a ... valid until Jan. 30, 2015. , Click strand ... hardwood. BambooFlooringChina.com is a well-known brand in the ... to find a reliable bamboo flooring supplier. , ...
(Date:12/25/2014)... 2014 Product liability lawsuits filed in ... ( http://www.consumerinjurylawyers.com/DePuy/ ) continue to move forward in federal ... issued in the U.S. District Court, Northern District of ... open conference on January 7, 2015, at the Paul ... West Palm Beach, Florida. The Conference is scheduled to ...
(Date:12/25/2014)... Recently, Dylan Queen, a famous online company supplying ... of discounted prom dresses, most of which are priced ... the company, the promotion is valid until Jan. 22, ... the UK market. , The prom dresses in this ... styles: A-line strapless, empire strapless chiffon, one shoulder, floor-length, ...
(Date:12/25/2014)... sells many bamboo products and the business is famous ... announces big discounts on its bamboo mats , which ... the world’s leader in bamboo flooring. According to the ... 2015. , The bamboo mats are made from well-treated ... the bamboo strips for the mats are boiled and ...
Breaking Medicine News(10 mins):Health News:Parker & Sons Announces Record Demand For 24 Hour Emergency Services In 2014 With Regard To Air-Conditioning Systems 2Health News:Parker & Sons Announces Record Demand For 24 Hour Emergency Services In 2014 With Regard To Air-Conditioning Systems 3Health News:BambooFlooringChina.com: click strand woven bamboo flooring promotion valid until Jan. 30, 2015. 2Health 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:Dylan Queen: Cheap Prom Dresses for the UK Market 2Health News:Various Styles of Bamboo Mats in Many Colors from BambooFlooringChina.com 2
... screening that combines an adjusted blood test with other factors ... and family history, can help up to one-quarter of men ... Israel Deaconess Medical Center-led research team says. Writing in ... the team led by Martin G. Sanda, MD, Director of ...
... in French . , Researchers have revealed ... the integrity of our genetic code, and when it is ... in the development of cancer. The University of Montreal scientists ... by using cutting edge microscopy techniques to visualize telomerase molecules ...
... By Amanda Gardner HealthDay Reporter , WEDNESDAY, ... they are heartened by the results of two new ... women with two different types of advanced tumors. ... in women with hormone receptor-positive breast cancer but is ...
... they are burned out and dissatisfied with their jobs, reported ... for Health Outcomes and Policy Research in a study of ... 60 percent of nurses reported symptoms of burnout according to ... in Health Care , which collected data from nurses in ...
... mycoestrogen zearalenone (ZEN), a naturally occurring toxin that widely ... breast cancer. That is the warning from breast health ... publication in the January issue of IJCP , ... "No clinical trials have been published on the use ...
... health care system in the United States faces numerous challenges: ... how to ensure more equitable use of medical services and, ... for that care. The 10th Biennial Regenstrief Institute ... Medical Care tackles key conceptual questions, reviews effective ...
Cached Medicine News:Health News:PSA testing, combined with other relevant patient data can reduce unnecessary prostate biopsies 2Health News:PSA testing, combined with other relevant patient data can reduce unnecessary prostate biopsies 3Health News:Scientists capture single cancer molecules at work 2Health News:Two New Drug Combos May Fight Advanced Breast Cancers 2Health News:Two New Drug Combos May Fight Advanced Breast Cancers 3Health News:To keep nurses, improve their work environments 2Health News:Women advised to avoid ZEN bust-enhancing supplements because of possible cancer risk 2Health News:Journal supplement presents strategies for introducing health care delivery innovation 2
Traditional design utility pliers have adjustable jaws. Good all purpose plier for handling Steinmann Pins, K-Wires, screws and rods. 10mm jaw tip....
The Wire Cutters are designed to cut Kirschner wires up to 2.5 mm diameter easily and smoothly. They are particularly useful for external fixation applications. The Wire Cutters shear fixation wires ...
Curved osteotome for bone removing....
... Spectral system is a combination Spectral Optical ... (SLO) system that provides suberb, high-quality images ... With the advancements of spectral technology, OTI's ... to 27,000 A-Scans per second and provide ...
Medicine Products: