Navigation Links
MAP Pharmaceuticals Reports No Difference in Pulmonary Artery Pressure Between LEVADEX™ and Placebo in Pharmacodynamics Trial

MOUNTAIN VIEW, Calif., Sept. 8 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today reported results from a pharmacodynamics (PD) trial comparing the acute effects on pulmonary artery pressure of LEVADEX™, dihydroergotamine mesylate (DHE) administered intravenously (IV) and placebo. In the trial, there was no statistically significant difference between the LEVADEX and placebo groups in the primary endpoint of pulmonary artery pressure over two hours after administration. LEVADEX is a novel orally inhaled migraine therapy that has completed Phase 3 efficacy development for the acute treatment of migraine.

LEVADEX was well tolerated and there were no drug-related serious adverse events reported. There were no clinically significant changes in any cardiovascular parameters measured in this trial. There were no mean increases in QT interval in the LEVADEX group. All pharmacokinetic results in this trial were consistent with those reported in previous LEVADEX trials."Intravenous DHE has been used safely for over 60 years, and we wanted to evaluate whether LEVADEX, with its novel administration through the lung, would have an effect on pulmonary artery pressure. We are pleased to report that LEVADEX did not have an effect on pulmonary artery pressure compared to placebo and was, in fact, less than that seen with IV DHE," said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals.

Pulmonary artery pressure in the IV DHE group was higher than both the LEVADEX and placebo groups. In addition, even after a second dose of LEVADEX was administered two hours after the first dose, pulmonary artery pressure was not higher in the LEVADEX group than in the IV DHE group.  

The PD trial was a randomized, double blind, placebo controlled, three-way, crossover trial in 24 healthy adults and was designed to compare the acute effects of LEVADEX, IV DHE and placebo on pulmonary artery pressure by taking regular echocardiogram measurements over a two hour period. The trial compared the PK of LEVADEX and IV DHE and its metabolites, the effects of both routes of delivery on cardiac function, including echocardiograph findings, 12-lead ECG, and vital signs. In addition, the trial evaluated the PD and PK of two doses of LEVADEX administered two hours apart as compared to a single dose of 1.0 mg IV DHE.


LEVADEX orally inhaled migraine therapy is a novel migraine therapy in Phase 3 development. Patients administer LEVADEX themselves using the company's proprietary TEMPO® inhaler. LEVADEX has been designed to be differentiated from existing migraine treatments. It is a novel formulation of dihydroergotamine (DHE), a drug used intravenously in clinical settings to effectively and safely treat migraines. Based on clinical results, the company believes that LEVADEX has the potential to provide both fast onset of action, sustained pain relief and other migraine symptom relief in an easy-to-use and non-invasive at-home therapy.

LEVADEX is designed to incorporate the multiple beneficial mechanisms of action that allow DHE to block initiation of migraine, limit pain, reduce inflammation and stop a migraine at any point in the migraine cycle. Based on research to date, including the efficacy portion of the FREEDOM-301 trial, the company believes the unique pharmacokinetic profile of LEVADEX has the potential to effectively treat migraines, while minimizing the side effects commonly seen with DHE and other currently available medicines.

About Migraine

Common symptoms of migraine include recurrent headaches, nausea, vomiting, photophobia (sensitivity to light) and phonophobia (sensitivity to sound). According to the National Headache Foundation, 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, according to published studies. Migraine patients report that currently approved drugs do not fully meet their needs due to slow onset of action, short duration of effect, inconsistent response and unacceptable side effect profiles. The economic burden of migraine remains substantial despite existing treatments, with the direct and indirect costs of migraine in the United States estimated at over $20 billion annually.

About MAP Pharmaceuticals

MAP Pharmaceuticals is dedicated to developing and commercializing new therapies for patients suffering from conditions that are not adequately treated by currently available medicines. The Company is developing LEVADEX inhaled therapy for the potential treatment of migraine and has reported positive results from the efficacy portion of the first Phase 3 trial of LEVADEX. In addition, MAP Pharmaceuticals generates new pipeline opportunities by applying its proprietary drug particle and inhalation technologies to enhance the therapeutic benefits of proven drugs, while minimizing risk by capitalizing on their known safety, efficacy and commercialization history.

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 MAP Pharmaceuticals' LEVADEX product candidate. Actual results may differ materially from current expectations based on risks and uncertainties affecting the Company's business, including, without limitation, risks and uncertainties relating to the conduct and completion of clinical trials, and relating to the preparation and filing of a New Drug Application and the regulatory process to have the Company's LEVADEX product candidate approved for commercial use. 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 for the quarter ended June 30, 2010, available at FoderaroWCG(415)

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

Related medicine technology :

1. Isis Pharmaceuticals to Present at the Stifel Nicolaus 2010 Healthcare Conference
2. MAP Pharmaceuticals Announces All Non-Asthmatic Patients Complete Treatment in Open-Label Trial and Completion of Treatment in QT Trial for LEVADEX™ Clinical Program
3. Transcept Pharmaceuticals to Present at Rodman & Renshaw and Stifel Nicolaus Investor Conferences in September 2010
4. Cadence Pharmaceuticals to Present at Four Investment Conferences During the Month of September 2010
5. Idenix Pharmaceuticals to Present at Two Upcoming Investor Conferences
6. MAP Pharmaceuticals to Present at Upcoming Healthcare and Scientific Conferences
7. Tibotec Pharmaceuticals Seeks European Marketing Authorization for Investigational Once-Daily HIV Treatment TMC278
8. Shanghai SynTheAll Pharmaceuticals Co., Ltd. (STA) Receives ISO 14001 Certification
9. Transdel Pharmaceuticals Presents Phase 3 Study Data on Ketotransdel® at World Pain Congress in Montreal, Canada
10. Optimer Pharmaceuticals Announces Presentations of Additional Fidaxomicin Phase 3 Data at Upcoming ICAAC Annual Meeting
11. Optimer Pharmaceuticals to Present at September 2010 Investor Conferences
Post Your Comments:
(Date:12/1/2015)... Sweden , December 1, 2015 ... Cancer Study Group (IBCSG, Bern ) and ... to be part of a state of the art trial, ... --> --> The study, ... treated with anti-hormonal therapy in combination with palbociclib, a cancer ...
(Date:11/30/2015)... BASEL, Switzerland , Dec. 1, 2015 ... through its wholly-owned UK subsidiary Proximagen Ltd., today announced ... novel, oral small molecule inhibitor of Vascular Adhesion Protein ... in the treatment of inflammatory disease. The VAP-1 inhibitor ... --> --> Under the terms ...
(Date:11/30/2015)... Asia,s largest exhibition and conference dedicated to the Medical Device ... 22 nd April 2016. --> --> ... --> -->   --> --> ... population and the government back up, the Medical Device is one of the ... . With the aging population and the government back up, the Medical ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... December 01, 2015 , ... Lutronic, a leading innovator ... the latest addition to the devices for sale in the United States. Clarity ... and long-pulsed 1064 nm Nd:YAG lasers, into a single platform that is easy to ...
(Date:12/1/2015)... CA (PRWEB) , ... December 01, 2015 , ... ... has selected 10 semi-finalists to head to Las Vegas for CES 2016, the world’s ... including CEO of Consumer Technology Association Gary Shapiro, Founding Partner of Pacific Investments Veronica ...
(Date:12/1/2015)... ... 2015 , ... Nurotron Biotechnology Co., Ltd., maker of cochlear implant systems, has ... The order will be from the China Disabled Persons’ Federation, a central government association, ... solution for children and adults suffering from severe and profound hearing loss . ...
(Date:12/1/2015)... ... December 01, 2015 , ... Tympani Inc., announced ... (ATP) status from Cisco. This designation recognizes Tympani as having fulfilled the training ... solutions targeted to the high-end enterprise contact center marketplace. , Ed Kapelinski, President ...
(Date:11/30/2015)... , ... November 30, 2015 , ... Trevor and Taylor ... as they play for the chance to represent the United States. This hybrid ... to be a part of their journey in addition to offering corporate sponsors with ...
Breaking Medicine News(10 mins):