MAP Pharmaceuticals, Inc. (MAPP) to Present Additional Data Analyses From LEVADEX(TM) FREEDOM-301 Trial at 2010 European Headache and Migraine Trust International Congress
10/20/2010 9:14:19 AM
MOUNTAIN VIEW, Calif., Oct. 20 /PRNewswire-FirstCall/ --MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced that the Company will present nine analyses relating to its LEVADEX orally inhaled migraine therapy product candidate, including analysis from the FREEDOM-301 Phase 3 trial, at the 2010 European Headache and Migraine Trust International Congress (EHMTIC) in Nice, France. EHMTIC is a biennial congress of the Migraine Trust and the European Headache Federation for neurologists, physicians, scientists, researchers, international experts and healthcare professionals.
An oral platform presentation titled "Utility of LEVADEX in Situations Where Early Intervention Paradigm is Impractical" reports 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 Migraine-Clinical Experiment Studies session on Sunday, October 31 at 10:40 a.m. CEST. This will also be presented as a poster (#322) starting Saturday, October 30 at 9:00 a.m. CEST.
In addition, two new analyses from the LEVADEX program will be presented in poster presentations. Poster number 460, "The Major Metabolite of Dihydroergotamine (DHE) After Oral Inhalation and IV Administration Does Not Significantly Contribute to the Pharmacological Activity," will be presented starting Thursday, October 28 at 12:00 p.m. CEST. Poster number 471, "Migraine Recurrence Rates: Case for Standardization of the Definition," will be presented starting Saturday, October 30 at 9:00 a.m. CEST.
Six additional poster presentations also will be presented in two separate sessions:
Thursday, October 28 at 12:00 p.m. CEST
- Efficacy Evaluation of LEVADEX in Treating a Broad Spectrum of Acute Migraine Attacks (#463)
- Evaluation of Safety and Efficacy of LEVADEX (MAP0004) in Treating Acute Menstrual Migraine (#465)
- Evaluation of Efficacy and Safety of LEVADEX (MAP0004) in Reversing Central Sensitization and Treating Migraine in Established Allodynic Patients (#466)
Saturday, October 30 at 9:00 a.m. CEST
- LEVADEX, a Novel Orally Inhaled Treatment for Acute Migraine: Efficacy and Tolerability Results of a Phase 3 Study (#462)
- Efficacy Evaluation of LEVADEX in Treating Resistant Migraine Including Migraine with Allodynia, Morning Migraine, Disabling Migraine and Migraine Treated Late (#464)
- The Efficacy and Tolerability of LEVADEX (Orally Inhaled DHE) for the Treatment of Migraine in Subjects with Concomitant Asthma (#467)
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 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 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.
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.
SOURCE MAP Pharmaceuticals, Inc.