MOUNTAIN VIEW, Calif., June 10 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced that the Company will present new analyses from the FREEDOM-301 Phase 3 trial of its investigational LEVADEX™ orally inhaled migraine therapy. The post hoc analyses will be presented at the 52nd Annual Scientific Meeting of the American Headache Society (AHS) in Los Angeles, California.
The late-breaker oral presentation titled "Utility of LEVADEX™ in Situations Where Early Intervention Paradigm is Impractical" evaluates the efficacy of LEVADEX in treating acute migraine at different time points during an attack, as early as initial migraine onset and as late as eight hours after onset of a migraine attack. It will be presented by Stewart Tepper, M.D., Director of Research for the Center for Headache and Pain at the Cleveland Clinic, during the late-breaker session on Friday, June 25 from 3:30 to 4:00 pm PT.
The poster presentation titled "The Efficacy and Tolerability of LEVADEX™ (Orally Inhaled DHE) for the Treatment of Migraine in Subjects with Concomitant Asthma—A Subgroup Analysis" evaluates the safety and efficacy of LEVADEX in this subpopulation. It will be presented on Friday, June 25 from 12:30 – 1:30 pm PT.
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.
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.