Navigation Links
MAP Pharmaceuticals Initiates Phase 3 Clinical Trial in Patients With Migraine

MOUNTAIN VIEW, Calif., July 14 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced it has initiated its Phase 3 clinical program to evaluate MAP0004 as a potential treatment for migraine.

MAP0004 is orally inhaled and self-administered at home using MAP Pharmaceuticals' proprietary Tempo(R) inhaler. In the company's prior Phase 2 efficacy study, MAP0004 provided pain relief in as fast as 10 minutes, with relief sustained through at least 24 hours. The study also demonstrated efficacy trends in treating nausea, photophobia and phonophobia, the other key measurements in treating migraine.

This randomized, double-blind, placebo-controlled Phase 3 trial is designed to evaluate the efficacy and safety of MAP0004 in treating acute migraine. The primary efficacy endpoints will be pain relief, and freedom from nausea, photophobia and phonophobia as measured at two hours after dosing. MAP will also evaluate earliest onset of pain relief and sustained relief to 24 and 48 hours. The multi-center efficacy trial will include approximately 850 patients, who will also be followed for 12 months in an open-label study to confirm long-term safety.

"We believe that MAP0004 has the potential to be a first-line therapy for migraine patients," said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals. "Based on our initial clinical studies, we believe that MAP0004 offers an alternative to triptans that may provide patients with the benefits of rapid onset and long-lasting pain relief, in an easy-to-use, non-invasive, at-home therapy. In our Phase 2 trials, MAP0004 was well tolerated with no effect on pulmonary function, including in asthmatic subjects."

The therapeutic agent in MAP0004 is dihydroergotamine (DHE), which has a long history of use as a safe and effective migraine treatment. Many headache specialists consider DHE administered by injection to be the standard of care in treating chronic migraine and debilitating migraines that last more than 72 hours. MAP Pharmaceuticals is seeking to expand the use of this compound to treat migraines early, non-invasively and with a fast onset of action.

MAP Pharmaceuticals is initiating the first Phase 3 trial of its MAP0004 product candidate pursuant to a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration. The SPA is intended to provide assurance that if pre-specified trial results are achieved, they may serve as the primary basis for an efficacy claim in support of a new drug application. In general, these assessments are considered binding on the FDA as well as the sponsor unless public health concerns unrecognized at the time the SPA is entered into become evident or other new scientific concerns regarding product safety or efficacy arise.

About Migraine

Migraine is a common, debilitating neurological disease affecting approximately 30 million people in the United States. It presents with recurrent attacks of headaches, nausea, vomiting and sensitivity to light and sound. Most migraines last between four and 24 hours, but some last as long as three days. On average, migraine sufferers experience 1.5 migraine attacks monthly, although 25 percent of them experience one or more attacks weekly.

In published studies, migraine sufferers often cite faster onset of pain relief and lower incidence of migraine recurrence as two key therapeutic attributes they would like from their medication. Currently approved drugs for the treatment of an acute migraine attack do not fully meet the needs of all patients due to the slow onset of action, short duration of effect, inconsistent response, unacceptable side effect profiles, or propensity to increase frequency of headaches with these therapies.

In 2007, triptans, the class of drugs most often prescribed for treating migraine, generated sales of approximately $2.2 billion in the United States, according to data published by IMS Health. Approximately 30 to 40 percent of migraine patients do not respond fully to triptans. Historically, estimated onset of significant pain relief with oral triptans occurs between 45 and 90 minutes after dosing.

About MAP Pharmaceuticals, Inc.

MAP Pharmaceuticals develops and plans to commercialize new therapies for children and adults who suffer from chronic conditions that it believes are not adequately treated by currently available medicines. The company applies its proprietary inhalation technologies to enhance the therapeutic benefits and commercial attractiveness of proven drugs while minimizing risk by capitalizing on their known safety, efficacy and commercialization history. MAP Pharmaceuticals has two drug candidates in Phase 3 clinical trials. Unit Dose Budesonide is being developed for the potential treatment of pediatric asthma, and MAP0004 is being developed for the potential treatment of migraine. MAP Pharmaceuticals' pipeline also includes a drug candidate in early clinical development for the treatment of asthma and chronic obstructive pulmonary disease.

Additional information about MAP Pharmaceuticals can be found at

Forward-Looking Statements

In addition to statements of historical facts or statements of current conditions, this press release contains forward-looking statements, including with respect to the outcomes of the MAP0004 clinical program. Actual results may differ materially from current expectations based on risks and uncertainties affecting MAP Pharmaceuticals' business, including, without limitation, risks and uncertainties relating to the enrollment and conduct of clinical trials, as well as risk related to failure to achieve favorable clinical outcomes and that MAP0004 will not be approved for commercial use by the U.S. Food and Drug Administration, including but not limited to approval for use as a first line therapy. The reader is cautioned not to unduly rely on the forward-looking statements contained in this press release. MAP Pharmaceuticals expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. Additional information on potential factors that could affect MAP Pharmaceuticals' results and other risks and uncertainties are detailed in its Quarterly Report on Form 10-Q, filed with the SEC on May 14, 2008, and available at

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

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. ( 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:
(Date:11/25/2015)... , Nov. 25, 2015  Linden Care, LLC, ... optimizing treatment outcomes for patients suffering from chronic pain, ... for a Temporary Restraining Order (TRO) enjoining Express Scripts ... two companies. --> --> ... all of its legal options. --> ...
(Date:11/25/2015)... 25, 2015 On Tuesday, November 24, ... trial against Wright Medical Technology, Inc. for product ... metal-on-metal hip implant device, awarded $11 million in ... week trial and three days of deliberations, the ... was defectively designed and unreasonably dangerous, and that ...
(Date:11/25/2015)... , Nov. 25, 2015  Henry Schein, Inc., ... services to office-based dental, medical and animal health practitioners, ... Meeting the Henry Schein ConnectDental® Pavilion , which ... array of open solutions designed to help any practice ... Click here for a schedule of experts appearing ...
Breaking Medicine Technology:
(Date:11/25/2015)... CA (PRWEB) , ... November 25, 2015 , ... According ... Vinci surgical robot is being more and more widely heralded as a breakthrough for ... da Vinci method has over traditional laparoscopic surgery is that it can greatly reduce ...
(Date:11/25/2015)... Boca Raton, Florida (PRWEB) , ... November 25, ... ... on-site diagnostic testing for physicians and athletic programs, launches new Wimbledon Athletics ... the importance of testing young athletes for unsuspected cardiac abnormalities. About 2,000 people ...
(Date:11/25/2015)... (PRWEB) , ... November 25, 2015 , ... ... a double board certified facial plastic surgeon specializing in both surgical and non-surgical ... of The Skin Spa at Hobgood Facial Plastic Surgery. , Highly trained ...
(Date:11/25/2015)... , ... November 25, 2015 , ... “While riding the ... inventor, from Bronx, N.Y. “I thought there had to be a convenient and comfortable ... PROTECTOR. , The PROTECTOR enables disabled individuals to safely travel during cold or inclement ...
(Date:11/25/2015)... ... 25, 2015 , ... "When I underwent breast reconstruction following ... uncomfortable," said an inventor from Bronx, N.Y. "In order to meet my own ... BRA for added comfort and support. The bra is easier to put on ...
Breaking Medicine News(10 mins):