Navigation Links
MAP Pharmaceuticals Announces FDA Acceptance for Filing of NDA for LEVADEX®
Date:8/2/2011

impact of CYP3A4 inhibition on LEVADEX pharmacokinetics. There were no drug related serious adverse events reported in any LEVADEX trial.  

About LEVADEX®

LEVADEX is an investigational drug for the acute treatment of migraine in adults, for which the Company has submitted a New Drug Application to the U.S. Food and Drug Administration. In the clinical trial, patients administered LEVADEX themselves using the proprietary TEMPO® inhaler. LEVADEX contains a novel formulation of dihydroergotamine (DHE).  LEVADEX was evaluated in the efficacy portion of FREEDOM-301, MAP Pharmaceuticals' Phase 3 pivotal trial, which included 395 patients in the LEVADEX arm and 397 patients in the placebo arm.  In the Phase 3 trial, patients taking LEVADEX had statistically significant improvement at two hours compared to patients on placebo for all four co-primary endpoints:

  • Pain relief: 58.7 percent of patients who received LEVADEX compared with 34.5 percent for placebo (p<0.0001);
  • Phonophobia free: 52.9 percent of patients who received LEVADEX compared with 33.8 percent for placebo (p<0.0001);
  • Photophobia free: 46.6 percent of patients who received LEVADEX compared with 27.2 percent for placebo (p<0.0001); and
  • Nausea free: 67.1 percent of patients who received LEVADEX compared with 58.7 percent for placebo (p=0.02).

The most common adverse event reported in the trial was medication aftertaste at six percent versus two percent for placebo.  The next most common adverse event was nausea at five percent compared with two percent for placebo.  There were no decreases in lung function, as measured by spirometry, between the active and placebo groups. 

About Migraine

Migraine is estimated to occur in 18% of women and 6% of men in the United States.  Over 30 million people are impacted by the often debi
'/>"/>

SOURCE MAP Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
2. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
3. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
4. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
5. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
6. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
7. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
8. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
9. Access Pharmaceuticals Provides Update on Clinical Development Plan of ProLindac
10. Quark Pharmaceuticals Extends Research Agreement with State University of New York for Proprietary siRNA Compounds for Acute Hearing Loss
11. Acura Pharmaceuticals, Inc. Secures Financing to Fund Pivotal Phase III Clinical Trial for Lead Aversion(R) Technology Product Candidate
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/27/2015)... 27, 2015  The quality function within the medical ... meet quality standards at every stage of the product ... leaders also have the challenge of balancing quality and ... who don,t effectively balance these priorities risk funding and ... failure and regulatory scrutiny. For the third ...
(Date:3/27/2015)... March 27, 2015 Levi & Korsinsky announces ... (NASDAQ: OHRP ) concerning possible violations of federal ... the Company in connection with its study of the ... http://zlk.9nl.com/ohr-pharmaceutical-ohrp or contact Joseph E. Levi, Esq. ... by telephone at (212) 363-7500, toll-free: (877) 363-5972. ...
(Date:3/27/2015)... WINNIPEG , March 27, 2015 /PRNewswire/ - Medicure ... Board of Directors has approved the grant of an ... management company employees and consultants of the Company pursuant ... 181,070 are set to expire on the tenth anniversary ... expire on the third anniversary of the date of ...
Breaking Medicine Technology:New Medical Device Quality Study Finds Regulatory Environment is Boosting Quality Spending, Especially for Large Companies 2
... Terumo Heart Inc., a wholly owned subsidiary of ... the worldwide expansion of its DuraHeart(TM) Left-Ventricular Assist System ... Arusoglu, MD and Michiel Morshuis, MD, cardiothoracic surgeons at ... Diabetes Center NRW, University Hospital of the Ruhr-University of ...
... select markets worldwideNATICK, Mass., May 19 Boston ... announced the launch of the platinum chromium TAXUS(R) ... worldwide. The TAXUS Element Stent features a ... stent applications and represents the Company,s third-generation drug-eluting ...
Cached Medicine Technology:Terumo Heart, Inc. Reaches Clinical Milestone as the 100th Patient Worldwide Receives the DuraHeart(TM) Left Ventricular Assist System 2Terumo Heart, Inc. Reaches Clinical Milestone as the 100th Patient Worldwide Receives the DuraHeart(TM) Left Ventricular Assist System 3Terumo Heart, Inc. Reaches Clinical Milestone as the 100th Patient Worldwide Receives the DuraHeart(TM) Left Ventricular Assist System 4Boston Scientific Launches Third-Generation Platinum Chromium Drug-Eluting Stent 2Boston Scientific Launches Third-Generation Platinum Chromium Drug-Eluting Stent 3Boston Scientific Launches Third-Generation Platinum Chromium Drug-Eluting Stent 4Boston Scientific Launches Third-Generation Platinum Chromium Drug-Eluting Stent 5
(Date:3/28/2015)... Servpro of Paso Robles , ... report about the link between mold and asthma. Mold ... to recent medical research, may even cause asthma in ... Protection Agency, people with sensitivity to mold or mold ... trigger asthma attacks for asthma sufferers. The EPA recommends ...
(Date:3/27/2015)... March 27, 2015 In her mid-forties and ... her from working, Monica K. arrived at JET Uniform ... department quiet, defensive and scared. The owners and staff at ... Services (EPSS) to offer jobs to challenged residents like ... and a willingness to begin with the end in mind,” ...
(Date:3/27/2015)... 27, 2015 Bleeding is one ... percutaneous coronary intervention (PCI), resulting in increased mortality, ... “risk-treatment paradox,” in which the highest-risk PCI patients ... treated less often with bleeding avoidance strategies than ... Mid America Heart Institute asked the question whether ...
(Date:3/27/2015)... NY (PRWEB) March 27, 2015 Ticket Down is ... Concert in 2015. After a phenomenal and highly successful ... "Nashville" will be going out on tour again in 2015 and ... tour gets underway on April 29th in New York City at ... at the Comerica Theatre on May 10th. , Fans of the ...
(Date:3/27/2015)... According to a recently published report series ... screw market in Europe is in decline due to ... segment. Price decreases are being seen across the entire ... the total European trauma device market, continued pricing pressure ... year after year. , “Such price drops are ...
Breaking Medicine News(10 mins):Health News:Water Damage Restoration Specialists Servpro of Paso Robles Release Report on Mold and Asthma 2Health News:Water Damage Restoration Specialists Servpro of Paso Robles Release Report on Mold and Asthma 3Health News:Red Deer Uniforms Shop Celebrates 3rd Year Sewing Hope for the Challenged 2Health News:Red Deer Uniforms Shop Celebrates 3rd Year Sewing Hope for the Challenged 3Health News:Precision Medicine Improves Use of Bleeding Avoidance Strategies and Reduces Bleeding in Patients Undergoing Percutaneous Coronary Intervention 2Health News:Precision Medicine Improves Use of Bleeding Avoidance Strategies and Reduces Bleeding in Patients Undergoing Percutaneous Coronary Intervention 3Health News:Nashville Live in Concert Tickets in New York, Boston, Washington, DC, Chicago, Minneapolis, San Francisco, Los Angeles and Phoenix Now On Sale at TicketDown.com 2Health News:Titanium Trauma Treatment Devices in Europe Becoming More Affordable, Decreasing Market Value: Group Purchasing Further Eroding Selling Prices 2Health News:Titanium Trauma Treatment Devices in Europe Becoming More Affordable, Decreasing Market Value: Group Purchasing Further Eroding Selling Prices 3
... ... youth-enhancing procedures, dermatologists question the impact the silver screen’s ageless face has on mainstream ... Anaheim, ... especially for female actresses. Carla Gugino, an actress of Night at the Museum, ...
... ... Free App for House Health Care Act , ... Comprehending the over 2000 pages contained within HR 3200, the House Bill ... become almost 40% easier for Americans thanks to a cooperative effort between Hearthebill.org and ...
... NEWPORT BEACH, Calif., Dec. 28 With the New Year just ... resolutions. , , Lose weight., ... underlying theme of most New Year,s resolutions is health-related, many tend ... visits to the doctor. Even more so, we forgo the regular ...
... Scientists have created what appears to be a schizophrenic ... in complex reasoning and decisions about appropriate social behavior. ... Dec. 28 in PNAS, elucidate the critical balance between ... go awry in schizophrenia. They also provide the first ...
... show up, but they,re there, study finds , MONDAY, Dec. 28 ... over the long term, a new study finds. , "There appears ... statement by Dr. Johan Arnlov, an associate professor of cardiovascular epidemiology ... Dec. 28 in the journal Circulation . , That assessment ...
... , , , , , ... obese nation. It,s no surprise then, battling the bulge becomes a ... to about.com). Experts preach to win the weight war; individuals must ... foods they eat. This year, Matterhorn and Crystal Light offer two ...
Cached Medicine News:Health News:Dermatologists Dissect Hollywood's Ageless Face Obsession 2Health News:House Health Care Bill Becomes Up To 38% More Understandable 2Health News:Celebrate the New Year With a New You 2Health News:Schizophrenia mouse model should improve understanding and treatment of the disorder 2Health News:Study Debunks Notion of 'Healthy Obese' Man 2Health News:Study Debunks Notion of 'Healthy Obese' Man 3Health News:Make Your 2010 Resolution and Chill Out with Crystal Light Frozen Treats 2
All Day Comfort for the Lower Body...
All Purpose, General Procedure Apron...
The Buckle Apron has a 2" wide belt with a rugged side-release buck. The belt and buckle are adjustable to provide a snug and comfortable fit while still offering .50mm Pb protection....
Features four-way apron closure for super adjustability to fit staff of all shapes and sizes. Top left and right shoulder closures allow adjustment of armhole size and chest area of apron for close a...
Medicine Products: