MOUNTAIN VIEW, Calif., June 23 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) announced today it will present new analyses from the FREEDOM-301 Phase 3 clinical trial in a late breaker session at the 52nd Annual Scientific Meeting of the American Headache Society (AHS) in Los Angeles, California on Friday, June 25 from 3:30 to 4:00 pm PT. The presentation will show that the Company's investigational LEVADEX™ orally inhaled migraine therapy was effective irrespective of when it was administered during a migraine cycle. Separately, the Company also will present efficacy and safety analyses of a subgroup of migraine patients with concomitant asthma.
The post hoc analysis, to be presented by Stewart Tepper, M.D., Director of Research for the Center for Headache and Pain at the Cleveland Clinic, showed LEVADEX was effective in treating a migraine attack with moderate or severe pain when administered as soon as the initial migraine onset and as late as eight hours after the start of the migraine. 771 patients treated a moderate to severe qualifying migraine, recorded efficacy and time to treatment data, and were included in this post hoc analysis. Two hour pain relief and two hour pain free rates were compared between active and placebo in those who treated their migraine within one hour, between one and four hours, between four and eight hours and greater than eight hours after the onset of the migraine.
"Several published studies have shown that the efficacy of triptans is reduced significantly when treatment is delayed. However, many patients may be unable or unwilling to treat migraine early in an attack," said Dr. Tepper. "Patients are looking to remedy this with a therapy that works when administered at any time during the migraine cycle."
A second post hoc analysis of the FREEDOM-301 trial data, to be presented in a poster session at AHS on Friday, June 25 from 12:30 - 1:30 pm PT, showed LEVADEX was both effective and well tolerated in migraine patients with asthma, a disorder commonly concomitant with migraine. Of 792 total patients who treated a migraine during the efficacy portion of the study, 80 were asthmatics and were included in the subanalysis. The efficacy results were consistent with the results of the entire study. In addition, the inhaled route of administration presented no significant differences in safety for migraine subjects with or without concomitant asthma.
A study evaluating the long term safety of LEVADEX for up to one year in migraine patients, including those with and without asthma, is ongoing.
As previously reported, LEVADEX met all four co-primary endpoints, as well as a number of secondary endpoints, and was well tolerated, with no drug related serious adverse events reported, in the efficacy portion of the FREEDOM-301 trial.
LEVADEX orally inhaled migraine therapy is in Phase 3 development for the potential acute treatment of migraine. Patients administer LEVADEX themselves using the Company's proprietary TEMPO® inhaler. In the Phase 3 FREEDOM-301 trial, LEVADEX met all four co-primary endpoints at two hours: pain relief (p<0.0001); phonophobia free (p<0.0001); photophobia free (p<0.0001); and nausea free (p=0.02). LEVADEX was well tolerated and there were no drug-related serious adverse events reported in the trial. Data from this Phase 3 trial show the potential for LEVADEX to be effective in treating acute migraine, as well as a broad spectrum of migraine subpopulations that are often difficult to treat with current therapies, including triptans. For example, in this trial, patients with allodynia, menstrual migraine, migraine with nausea and vomiting, severe migraine or who treated late in their migraine cycle responded well to LEVADEX.
LEVADEX is a novel formulation of dihydroergotamine mesylate (DHE), a drug used intravenously in clinical settings to effectively and safely treat migraines. It is designed to be differentiated from existing migraine treatments. Based on clinical results, the Company believes that LEVADEX has the potential to provide 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 other DHE-based products and other currently available migraine 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, and 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 orally inhaled therapy for the potential treatment of migraine and has reported positive results from the efficacy portion of its 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.
MAP Pharmaceuticals, Inc.
SOURCE MAP Pharmaceuticals, Inc.