Navigation Links
MAP Pharmaceuticals Submits New Drug Application to FDA for LEVADEX® Orally Inhaled Migraine Drug
Date:5/26/2011

MOUNTAIN VIEW, Calif., May 26, 2011 /PRNewswire/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced that it has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for LEVADEX® orally inhaled migraine drug for the potential acute treatment of migraine in adults. According to the National Headache Foundation, approximately 30 million people in the United States suffer from migraine, a debilitating neurological disorder. Common symptoms of migraine include recurrent headaches, nausea, phonophobia (sensitivity to sound) and photophobia (sensitivity to light).

"This NDA submission marks a major corporate milestone for MAP Pharmaceuticals and brings us one step closer to our goal of providing the underserved migraine patient population with a potential new treatment option," said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals. "Our comprehensive development program evaluated LEVADEX in approximately 1,000 patients for up to one year, treating nearly 10,000 migraines. If approved by the FDA, LEVADEX could potentially provide a new treatment option for migraine sufferers, including the millions of patients whose migraines are not well treated today."

The 505(b)(2) NDA submission is based on a comprehensive development program for LEVADEX, and includes efficacy and safety data from the Phase 3 FREEDOM-301 clinical trial that has been presented at scientific conferences and was recently published in Headache: The Journal of Head and Face Pain. In the FREEDOM-301 trial, patients self-administered LEVADEX at home using the Company's proprietary TEMPO® inhaler. LEVADEX contains a novel formulation of dihydroergotamine (DHE).  Patients taking LEVADEX in this pivotal trial had statistically significant improvement at two hours compared to patients on placebo for all four c
'/>"/>

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

Page: 1 2 3 4

Related biology technology :

1. Watson Acquires Specifar Pharmaceuticals
2. Auxilium Pharmaceuticals, Inc. Updates Launch Progress of XIAPEX® in EU
3. BioMarin to Present at the UBS Global Specialty Pharmaceuticals Conference
4. Watson Pharmaceuticals Announces New Research Showing RAPAFLO(R) (silodosin) Improves Outcomes for Chronic Prostatitis/Chronic Pelvic Pain Syndrome
5. Auxilium Pharmaceuticals, Inc. Announces First Quarter 2011 Financial Results and Operational Highlights
6. Inovio Pharmaceuticals Reports Long-Term Immune Responses from Therapeutic Cervical Dysplasia and Cancer DNA Vaccine
7. Vanda Pharmaceuticals Reports First Quarter 2011 Results
8. MAP Pharmaceuticals Reports First Quarter of 2011 Financial Results
9. Anadys Pharmaceuticals to Report First Quarter 2011 Financial Results
10. Keryx Biopharmaceuticals, Inc. Announces First Quarter 2011 Financial Results
11. Keryx Biopharmaceuticals, Inc. To Host Conference Call on First Quarter 2011 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/26/2015)... 2015   Regulus Therapeutics Inc . (NASDAQ: ... and development of innovative medicines targeting microRNAs, today announced ... Chief Executive Officer of Regulus, will present a company ... Annual Healthcare Conference on Wednesday, March 4, 2015 at ... the Boston Marriott Copley Place.  The ...
(Date:2/26/2015)...  NuGene International, Inc. ("NuGene") (OTCQB: NUGN), the ... hair rejuvenation, has announced that it has selected ... investor relations and strategic communications. ... diversification strategies – and we need to communicate ... Ali Kharazmi CEO of NuGene when announcing this ...
(Date:2/26/2015)... February 26, 2015 Innovation is ... emerging from unexpected parts of the world and ... From agriculture to manufacturing to health care, disruption ... environmental realities and socio-political trends shake the foundations ... key ingredient for CEOs to survive the next ...
(Date:2/26/2015)... Feb. 26, 2015 Ceres, Inc . ... in Oracle PartnerNetwork. In attaining Gold Level membership, Ceres ... establish Oracle-related knowledge in delivering Ceres, Persephone genome visualization ... customers. Originally developed for in-house use by ... in and out of massive amounts of genetic data, ...
Breaking Biology Technology:Regulus to Present at Cowen and Company 35th Annual Healthcare Conference 2Regulus to Present at Cowen and Company 35th Annual Healthcare Conference 3NuGene International, Inc. Selects Capital Market Relations for Strategic Investor Relations 2NuGene International, Inc. Selects Capital Market Relations for Strategic Investor Relations 3One Million Acts of Innovation Canada Creates Partnership with The Economist Events’ Innovation Forum 2Ceres Becomes Oracle PartnerNetwork Gold Level Partner 2Ceres Becomes Oracle PartnerNetwork Gold Level Partner 3Ceres Becomes Oracle PartnerNetwork Gold Level Partner 4
... NuMe Health LLC, a biotechnology company developing evidence-based ... disease status by modifying  the bacteria that live ... formation of its scientific advisory board (SAB). NuMe,s SAB ... the fields of nutrition, diabetes, obesity, health promoting ...
... 2011 , Spherix Incorporated (NASDAQ: ... therapy in diabetes, metabolic syndrome and atherosclerosis, and providers ... biotechnology and pharmaceutical companies – today announced the closing ... shares of its common stock together with warrants to ...
... 28, 2011 Nutra Pharma Corporation (OTCBB: NPHC), ... Multiple Sclerosis (MS), Human Immunodeficiency Virus (HIV/AIDS), Adrenomyeloneuropathy ... Executive Officer, Rik J. Deitsch, was interviewed by ... The interview provides an overview of the Company, ...
Cached Biology Technology:NuMe Health Advances its Cobiotics™ Technology With Addition of Scientific Advisory Board and Filing of Patent Application for First Product 2NuMe Health Advances its Cobiotics™ Technology With Addition of Scientific Advisory Board and Filing of Patent Application for First Product 3NuMe Health Advances its Cobiotics™ Technology With Addition of Scientific Advisory Board and Filing of Patent Application for First Product 4Spherix Announces Closing of Private Placement of $1.25 Million, Discusses Use of Proceeds 2Spherix Announces Closing of Private Placement of $1.25 Million, Discusses Use of Proceeds 3Nutra Pharma CEO Interviewed by Wall Street Reporter 2
(Date:2/23/2015)... -- NXT-ID, Inc. (NASDAQ: NXTD and ... focused on the growing mobile commerce market, announced today ... DISTRIBUTED VOICE DIRECTED PAYMENT METHOD AND SYSTEM. ... payment method. Payment accounts may be selected via voice ... if both the speech (the word associated with the ...
(Date:2/18/2015)... , Feb. 18, 2015  Cepheid (NASDAQ: CPHD ... the following conferences, and invited investors to participate via webcast. ... Boston, MA Tuesday, March 3, 2015 at 11.20 ... Orlando, FL Wednesday, March 4, 2015 ... To access the live webcasts for these events, please visit ...
(Date:2/12/2015)... Feb. 12, 2015   MedNet Solutions , ... clinical study management systems, has recently bolstered its ... distinguishing iMedNet as the ... (CROs) and healthcare consultants.  Building on the Program,s ... referrals and numerous co-marketing opportunities), MedNet,s new and ...
Breaking Biology News(10 mins):NXT-ID Patents Voice Directed Payments 2NXT-ID Patents Voice Directed Payments 3Cepheid to Webcast Upcoming Financial Presentations 2MedNet Solutions Announces Key Enhancements To Its iMedNet Partner Program 2
... Wayne State University researchers are testing a way to ... to healthier outcomes for mothers and their babies. ... Eunice Kennedy Shriver National Institute of Child Health and ... researchers will capture human fetal cells for genetic study ...
... flows in streams and rivers or on preserving only ... need a good mix of steep, cold-running streams and ... open for salmon adapted to reproduce better in one ... sort of varied landscape serves not just salmon, it ...
... available in German . Soil is ... incredible diversity, plants specifically choose certain species, give them access ... bacterial community from which they then benefit in a variety ... be able to tell which of these bacteria are friends ...
Cached Biology News:Wayne State researchers working to improve genetic analysis, disorder detection 2Bears, scavengers count on all-you-can-eat salmon buffet lasting for months 2Bears, scavengers count on all-you-can-eat salmon buffet lasting for months 3Bacterial community inside the plant root 2Bacterial community inside the plant root 3