Navigation Links
MAP Pharmaceuticals Reaches Agreement with FDA on Special Protocol Assessment for MAP0004 Phase 3 Clinical Trial in Patients With Migraine
Date:1/16/2008

MOUNTAIN VIEW, Calif., Jan. 16 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP), an emerging pharmaceutical company, today announced that it has completed the special protocol assessment (SPA) process with the U.S. Food and Drug Administration (FDA) for the first Phase 3 clinical trial of its MAP0004 product candidate, and has reached agreement with the Agency on the design of the protocol. The study, if successful, could support the potential approval of MAP0004 as a treatment for migraine.

"Following the positive results we saw in our Phase 2 trials, we are pleased to now have agreement with the FDA on the protocol for our first Phase 3 clinical trial to evaluate MAP0004 in migraine," stated Stephen Shrewsbury, M.B., Ch.B., Chief Medical Officer of MAP Pharmaceuticals. "We look forward to initiating this trial in early 2008."

This multi-center Phase 3 trial will include a randomized, double blind, placebo-controlled component to evaluate the efficacy and safety of MAP0004 in treating a single acute attack of migraine in approximately 850 patients followed by a 12-month open-label safety assessment. The primary efficacy endpoints will be pain relief at two hours, and freedom from nausea, photophobia and phonophobia at two hours.

About MAP0004

MAP0004 is a proprietary orally inhaled version of dihydroergotamine, or DHE, intended to treat migraine. The company's Phase 2 efficacy study showed that MAP0004 provided pain relief as early as within ten minutes of dosing, and that this relief was sustained through at least 24 hours. The study also demonstrated efficacy trends in treating nausea, photophobia and phonophobia. Based on these results, as well as independent research that concludes that p
'/>"/>

SOURCE MAP Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4

Related medicine news :

1. Access Licenses MuGard(TM) to RHEI Pharmaceuticals, a Leading Specialty Pharmaceutical Company for Distribution in China and Certain Other Southeast Asian Countries
2. Three Rivers Pharmaceuticals(R), LLC Acquires Hepatitis C Drug Infergen(R) from Valeant Pharmaceuticals
3. Cadence Pharmaceuticals Announces Topline Results of Two Phase III Clinical Trials of Acetavance(TM)
4. American Stock Exchange LLC to Delist Securities of Samaritan Pharmaceuticals, Inc.
5. NPS Pharmaceuticals to Present at the JPMorgan 26th Annual Healthcare Conference on January 9, 2008
6. ISTA Pharmaceuticals Submits New Drug Application for Xibrom(TM) QD (once-daily)
7. Law Offices of Howard G. Smith Announces 25 Days Remaining to Move to Be a Lead Plaintiff in the Shareholder Lawsuit Against Threshold Pharmaceuticals, Inc.
8. Idenix Pharmaceuticals to Present at the JP Morgan 26th Annual Healthcare Conference
9. Cogentus Pharmaceuticals Completes $62.5 Million Private Financing
10. Cumberland Pharmaceuticals Announces Appointments
11. Pacira Pharmaceuticals Names David M. Stack CEO and President
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/21/2013)... DISCcert has served the training industry ... 17 DISC applications at the July 25 & 26th ... The July 25 & 26th DISC certification in San ... applying DISC. The time-tested, proven support materials will include ... DISC training materials ; worksheets, handouts, learning activities, ...
(Date:5/21/2013)... York, New York (PRWEB) May 21, 2013 ... to protecting the rights of victims injured by defective ... Journal of Bone & Joint Surgery on May 15, ... can be used to identify complications that occur in ... any symptoms of failure. ( http://www.jbjs.org/article.aspx?articleid=1684770 ) ...
(Date:5/21/2013)... May 2013, Paris, France: The Orsiro stent, which ... a biodegradable polymer, demonstrated non-inferiority to the Xience ... of in-stent late lumen loss at nine months ... at EuroPCR 2013 today. , The BIOFLOW-II substudy ... (OCT) to quantitatively assess neointimal hyperplasia and stent ...
(Date:5/21/2013)... OR (PRWEB) May 21, 2013 Phoseon ... systems at the 20th Annual IMI European Ink ... a proven market leader, Phoseon continues to invest in ... accelerating the adoption of UV LED curing in printing ... product families on the market offering both air cooled ...
(Date:5/21/2013)... 2013) A paper recently published in the ... physicians and scientists at the University of Colorado School ... for pulmonary fibrosis can be used to identify individuals ... looked at a fairly common variant of the gene ... the mucous produced by the bronchial tubes. While this ...
Breaking Medicine News(10 mins):Health News:DISCcert Offers 17 Applications in Coming DISC Certification 2Health News:DISCcert Offers 17 Applications in Coming DISC Certification 3Health News:DISCcert Offers 17 Applications in Coming DISC Certification 4Health News:Parker Waichman LLP Comments on New Study Showing that MRI is Useful for Predicting Failure of Metal-on-Metal Hip Implants 2Health News:Parker Waichman LLP Comments on New Study Showing that MRI is Useful for Predicting Failure of Metal-on-Metal Hip Implants 3Health News:Biodegradable stent proves non-inferior to drug-eluting stent 2Health News:Researchers find genetic risk factor for pulmonary fibrosis 2
... women doctors and nurses have become quite common nowadays and ... against it.// , ,A recent study conducted in Kolkata, ... two government and two private hospitals over a period of ... doctors and nurses, including senior staff members revealed that sexual ...
... known for its lax regulations regarding booze often finds ... any person// in authority ever raising eyebrows until recently. ... prove that over forty two thousand Russians die annually ... closer scrutiny has also revealed that a majority of ...
... cheating the organisation he earlier worked for has been arrested ... Delhi Police arrested Alok Tomar, a former editor of Senior ... was arrested after he flew into the capital Friday night. ... of Police Alok Kumar. ,Kumar said Senior India ...
... give in to media pressure to give up ... slammed critics who pick on her for smoking ... Kate Moss. ,Said Miller: "With me ... it is deemed to be so cool. Why ...
... at the B.C. Roy Memorial Hospital here last week, laying ... back the horrors of 2002 when similar deaths occurred in ... 22 crib deaths since Thursday come at a time when ... controversy over using condemned blood testing kits, which are feared ...
... research to cure osteoarthritis without surgery and helped hundreds ... out promise of relief to the millions suffering from ... its kind in the world, the non-invasive treatment involves ... and tear due to ageing. ,Wing Commander ...
Cached Medicine News:Health News:Doctors, Nurses Face Sexual Harassment At Work Place 2Health News:Crib deaths revisit Kolkata hospital, 22 infants die 2Health News:Indian radiologist spearheads cure for osteoarthritis sans surgery 2Health News:Indian radiologist spearheads cure for osteoarthritis sans surgery 3
(Date:5/21/2013)... Md. , May 21, 2013 ... disposable drug-free consumer electronic devices, announced that CEO, ... presenting today to the FDA,s Medical Advisory Committee, ... the company,s products for over the counter sales. ... FDA developed its medical device classification schema," Whelan ...
(Date:5/21/2013)... 21, 2013 Reportlinker.com announces that ... in its catalogue:   ... Optical Coherence Tomography (OCT) ... OBJECTIVES   BCC,s ... offer synopsis of the current and future ...
(Date:5/21/2013)... TARRYTOWN, N.Y. , May 21, 2013 /PRNewswire/ ... Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the ... positive Phase 2a study results of dupilumab (SAR231893/REGN668) in ... monoclonal antibody targeting the alpha subunit of the interleukin ... IL-4 and IL-13, drivers of Th2 (Type 2 helper ...
Breaking Medicine Technology:BioElectronics Presents FDA Reclassification Panel 2BioElectronics Presents FDA Reclassification Panel 3Global Markets and Technologies for Optical Coherence Tomography (OCT) 2Global Markets and Technologies for Optical Coherence Tomography (OCT) 3Global Markets and Technologies for Optical Coherence Tomography (OCT) 4Global Markets and Technologies for Optical Coherence Tomography (OCT) 5Global Markets and Technologies for Optical Coherence Tomography (OCT) 6Global Markets and Technologies for Optical Coherence Tomography (OCT) 7Global Markets and Technologies for Optical Coherence Tomography (OCT) 8Global Markets and Technologies for Optical Coherence Tomography (OCT) 9Global Markets and Technologies for Optical Coherence Tomography (OCT) 10Global Markets and Technologies for Optical Coherence Tomography (OCT) 11Global Markets and Technologies for Optical Coherence Tomography (OCT) 12Global Markets and Technologies for Optical Coherence Tomography (OCT) 13Global Markets and Technologies for Optical Coherence Tomography (OCT) 14Global Markets and Technologies for Optical Coherence Tomography (OCT) 15Global Markets and Technologies for Optical Coherence Tomography (OCT) 16Global Markets and Technologies for Optical Coherence Tomography (OCT) 17Global Markets and Technologies for Optical Coherence Tomography (OCT) 18Global Markets and Technologies for Optical Coherence Tomography (OCT) 19Sanofi and Regeneron Announce Publication of Positive Phase 2a Results of Dupilumab in Asthma in the New England Journal of Medicine 2Sanofi and Regeneron Announce Publication of Positive Phase 2a Results of Dupilumab in Asthma in the New England Journal of Medicine 3Sanofi and Regeneron Announce Publication of Positive Phase 2a Results of Dupilumab in Asthma in the New England Journal of Medicine 4Sanofi and Regeneron Announce Publication of Positive Phase 2a Results of Dupilumab in Asthma in the New England Journal of Medicine 5Sanofi and Regeneron Announce Publication of Positive Phase 2a Results of Dupilumab in Asthma in the New England Journal of Medicine 6Sanofi and Regeneron Announce Publication of Positive Phase 2a Results of Dupilumab in Asthma in the New England Journal of Medicine 7
... N.Y., Dec. 22 Cold Spring Publishing, LLC, announced ... change to Harborside Press, LLC. , In addition, Harborside Press ... over the past year requires a substantial expansion in personnel and ... the new offices of Harborside Press will be located at 37 ...
... , JACKSON, Miss., Dec. 22, 2009 University of ... VISICU e ICU® Program to enhance care of the critically ... in the region to implement the eICU Program, UMHC will serve ... UMHC is using the Philips VISICU eICU Program and ...
Cached Medicine Technology:University of Mississippi Health Care Implements Philips VISICU eICU(R) Program 2University of Mississippi Health Care Implements Philips VISICU eICU(R) Program 3
The cementless acetabular shells form part of the Mallory head range of femoral and acetabular implants....
Trident Hemispherical Acetabular Shells are a true hemispherical shape designed to achieve press-fit fixation by under-reaming the acetabulum....
For primary and revision cases...
The Protract stem offers a press-fit option which will allow choice of standard or lateralized neck offsets while keeping a consistent leg length....
Medicine Products: