MOUNTAIN VIEW, Calif., July 16 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. announced that the positive results from a Phase 2 study evaluating the safety, tolerability and pharmacokinetics of MAP0004 in adult asthmatics were published in the July issue of Current Medical Research and Opinion. MAP Pharmaceuticals is developing MAP0004, an orally inhaled and self-administered therapy, as a potential treatment for migraine.
The study results, which were first announced last year, demonstrated that treatment with MAP0004 resulted in rapid and efficient systemic absorption of the therapeutic compound, dihydroergotamine (DHE), in asthmatic subjects, and that absorption was comparable to that observed in a previous study of healthy volunteers.
"Asthma and migraine have a high incidence of co-morbidity, so it was important to evaluate MAP0004 in patients with compromised pulmonary function," said Thomas A. Armer, Ph.D., chief scientific officer of MAP Pharmaceuticals. "In the study, MAP0004 was well tolerated by asthmatics with no effect on pulmonary function and with no serious adverse events reported."
About the Phase 2 Study
The Phase 2 study was a randomized, double-blind, placebo-controlled, crossover study of MAP0004 in 19 adult asthmatics. Each patient received three doses, one every week in randomized order over a 15-day period, including two 1.0 mg doses of MAP0004 and one dose of placebo. The 1.0 mg dose is twice the dose being studied in MAP Pharmaceuticals' Phase 3 trial. Spirometry was performed and blood draws were obtained at screening and at multiple times during each visit.
The study indicated that MAP0004 was well tolerated by subjects with compromised lung function, and that the pharmacokinetics of MAP0004 was similar to that experienced by adults with healthy lungs as shown in an earlier Phase 1 study. No serious adverse events were reported. In addition, no clinically significant changes were observed in pulmonary function tests or mean IgE levels, a measure of systemic immune response.
About MAP0004
In another Phase 2 efficacy study presented last year, MAP0004 provided pain relief in as fast as ten 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.
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.
MAP0004 is orally inhaled and self administered at home using the company's proprietary Tempo(R) inhaler, a novel pressurized metered dose inhaler that synchronizes the discharge of drug with the patient's breathing cycle. The Tempo inhaler can be optimized for each therapy based on desired delivery, and is designed to dispense drug in an efficient and consistent manner to minimize dose-to-dose differences in and between patients. The inhaler is convenient and easy to use, and contains a dose counter that can lock out after a maximum number of doses.
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 http://www.mappharma.com.
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 our 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. 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 http://edgar.sec.gov.
CONTACT: Becky Soja of WeissComm Partners, +1-415-945-1080,
bsoja@wcpglobal.com, for MAP Pharmaceuticals, Inc.
Web site: http://www.mappharma.com//
