MOUNTAIN VIEW, Calif., April 12, 2011 /PRNewswire/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced that the Company will present new data from two safety studies of LEVADEX® orally inhaled migraine drug. The data will be presented at the 63rd Annual Meeting of the American Academy of Neurology (AAN) in Honolulu, Hawaii April 9-16, 2011. LEVADEX is an investigational acute drug for migraine that has completed Phase 3 clinical development.
Findings to be presented at 2:00 p.m. HAST today in the poster titled "An Open-Label, 2-Period, Crossover Study Comparing the Pharmacokinetics and Tolerability of LEVADEX (MAP0004, Orally Inhaled DHE) and Intravenous DHE (DHE45) in Smoking and Non-Smoking Adult Volunteers," show that:
- LEVADEX exposure was not higher in smokers, potentially due to reduced pulmonary absorption
- LEVADEX was quickly absorbed into the bloodstream of both smokers and non-smokers, as evidenced by a median Tmax of 4.98 and 7.02 minutes respectively
- The mean half-life for LEVADEX was similar for smokers (16.1 hours) and non-smokers (14.5 hours) and was similar to IV DHE administration (13.3 hours for smokers and 12.4 hours for non-smokers)
- Tolerability of LEVADEX was similar in smokers and non-smokers
Findings in a separate safety study to be presented at 2:00 p.m. HAST today in the poster titled "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," show that:
- Neither LEVADEX, IV DHE nor placebo produced clinically significant changes in pulmonary arterial systolic pressure (PASP) or other cardiac functions; however a statistically higher elevation of PASP was found following IV DHE treatment compared to the LEVADEX and placebo treatment
- There was no statistical difference in PASP between the LEVADEX and placebo groups over two hours
- No significant electrocardiogram (ECG) changes were observed
- Adverse events were more frequent in the IV DHE group than in the LEVADEX or placebo groups
The three additional LEVADEX related presentations are:
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
This presentation has been selected by the Scientific Program Subcommittee to be in the top five percent of the American Academy of Neurology presentations and, as such, LEVADEX will be highlighted by the Subcommittee during the Scientific Program Highlights Plenary Session on Friday, April 15, 5:15 – 6:15 p.m.
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 drug for migraine that has completed Phase 3 clinical development. In the clinical trial, patients administered LEVADEX themselves using the proprietary TEMPO® 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 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 three 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, an orally inhaled investigational drug for the acute treatment of migraine. The Company has reported positive results from its Phase 3 trial of LEVADEX and has entered into a collaboration agreement with Allergan, Inc. to co-promote LEVADEX to neurologists and pain specialists in the U.S. MAP Pharmaceuticals also applies its proprietary drug particle and inhalation technologies to generate new pipeline opportunities by enhancing 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 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 Annual Report on Form 10-K for the year ended December 31, 2010, available at http://edgar.sec.gov.
MAP Pharmaceuticals, Inc.
SOURCE MAP Pharmaceuticals, Inc.