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.
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 http://www.mappharma.com.
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 http://edgar.sec.gov.CONTACTS:Nicole FoderaroWCG(415) email@example.com
|SOURCE MAP Pharmaceuticals, Inc.|
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