MAP Pharmaceuticals to Present Data on LEVADEX(TM) at the 63rd Annual Meeting of the American Academy of Neurology
MOUNTAIN VIEW, Calif., Feb. 28, 2011 /PRNewswire/ — MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced that LEVADEX(TM) orally inhaled migraine therapy will be featured in one oral presentation and four poster presentations at the 63rd Annual Meeting of the American Academy of Neurology (AAN) in Honolulu, Hawaii April 9-16, 2011. A summary of the Company’s AAN presentations is below, and the abstracts can be accessed at the AAN website at www.aan.com. LEVADEX is an investigational acute therapy for migraine that has completed Phase 3 clinical development.
Utility of LEVADEX (MAP0004) in Situations Where Early Intervention Paradigm Is Impractical Session Info: Platform Session: April 12, 2011, 3:00-4:30 p.m. HAST Presentation Info: April 12, 2011 at 3:45 p.m. HAST Presentation #: 004 An Open-Label, 2-Period, Crossover Study Comparing the Pharmacokinetics and Tolerability of LEVADEX (MAP0004, Orally Inhaled DHE) and Intravenous DHE (DHE45(R)) in Smoking and Non-Smoking Adult Volunteers Session Info: Poster Session 3: April 12, 2011, 2:00-6:00 p.m. HAST Poster #: 028 A Randomized, Double-Blind, Placebo Controlled, Three-Period Crossover Study Comparing the Acute Effects of LEVADEX (MAP0004, Orally Inhaled DHE) and Intravenous DHE on Pulmonary Arterial Systolic Pressure Session Info: Poster Session 3: April 12, 2011, 2:00-6:30 p.m. HAST Poster #: 029 The Major Metabolite of Dihydroergotamine (DHE) after Oral Inhalation and IV Administration Does Not Significantly Contribute to the Pharmacologic Activity Session Info: Poster Session 5: April 13, 2011, 2:00-6:30 p.m. HAST Poster #: 272 Migraine Recurrence Rates: Case for Standardization of the Definition Session Info: Poster Session 5: April 13, 2011, 2:00-6:30 p.m. HAST Poster #: 285
LEVADEX is an investigational acute therapy for migraine that has completed Phase 3 clinical development. In the clinical trial, patients administered LEVADEX themselves using the proprietary TEMPOÃ‚® inhaler. LEVADEX contains a novel formulation of dihydroergotamine (DHE). LEVADEX was evaluated in the efficacy portion of FREEDOM-301, MAP Pharmaceuticals’ Phase 3 pivotal trial, which included 395 patients in the LEVADEX arm and 397 patients in the placebo arm. In the Phase 3 trial, patients taking LEVADEX therapy had statistically significant improvement at two hours compared to patients on placebo for all four co-primary endpoints:
- Pain relief: 58.7 percent of patients who received LEVADEX compared with 34.5 percent for placebo (p<0.0001);
- Phonophobia free: 52.9 percent of patients who received LEVADEX compared with 33.8 percent for placebo (p<0.0001);
- Photophobia free: 46.6 percent of patients who received LEVADEX compared with 27.2 percent for placebo (p<0.0001); and
- Nausea free: 67.1 percent of patients who received LEVADEX compared with 58.7 percent for placebo (p=0.02).
The most common adverse event reported was medication aftertaste at six percent versus two percent for placebo. The next most common adverse event was nausea at five percent compared with two percent for placebo. There were no decreases in lung function, as measured by spirometry, between the active and placebo groups.
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. 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 an emerging biopharmaceutical company focused on developing and commercializing new therapies to address undermet patient needs in neurology. 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
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 development and regulatory approval process for the Company’s LEVADEX product candidate. 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 September 30, 2010, available at http://edgar.sec.gov.
CONTACTS: Nicole Foderaro Lisa Borland WCG MAP Pharmaceuticals, Inc. (415) 215-5643 650-386-3122 firstname.lastname@example.org
SOURCE MAP Pharmaceuticals, Inc.