MAP Pharmaceuticals to Present Data on LEVADEXÂ® at the 53rd Annual Scientific Meeting of the American Headache Society
MOUNTAIN VIEW, Calif., June 2, 2011 /PRNewswire/ — MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced that the Company will present safety data on LEVADEX(Ã‚®) orally inhaled migraine drug at the 53rd Annual Scientific Meeting of the American Headache Society (AHS) in Washington, DC, June 2-5, 2011. LEVADEX is an investigational acute drug for migraine and the Company has submitted a New Drug Application to the U.S. Food and Drug Administration for the potential acute treatment of migraine in adults.
Late-breaking presentations include:
- A Long-Term Open-Label Study Assessing the Safety and Tolerability of LEVADEX Orally Inhaled Dihydroergotamine in Adult Migraineurs: In this study, LEVADEX was well-tolerated for the acute treatment of migraine, and did not appear to be associated with any unique safety risk from the inhaled mode of administration.
- Nausea Associated with Dihydroergotamine (DHE) Is a Function of Maximum Concentration and Not Route of Administration: Nausea appears to be related to DHE Cmax irrespective of route of administration. In pooled analyses across three recent clinical studies, the Cmax after 1.0 mg via oral inhalation (LEVADEX) was consistently associated with a low incidence of nausea. This abstract has been selected for oral platform presentation and will be presented during the Scientific Paper Presentations – Session 3 on Saturday, June 4, 2:15 p.m. – 3:45 p.m. ET.
- Assessment of Cardiac Safety of LEVADEX Orally Inhaled Dihydroergotamine (DHE): In both acute and chronic evaluations with LEVADEX, no significant changes on any of the ECHO or ECG parameters evaluated were observed. Also, no significant changes in QT interval were observed at doses as high as three times the intended therapeutic LEVADEX dose.
Other presentations include:
- A Thorough QT Study Comparing Supratherapeutic Dose of Orally Inhaled DHE, Moxifloxacin, and Placebo on the QT Interval in Healthy Volunteers: A supratherapeutic dose of orally inhaled DHE, three times the intended clinical LEVADEX dose, did not prolong QTc intervals.
- A Drug Interaction Study Assessing the Effects of CYP3A4 Inhibition on the Pharmacokinetics of LEVADEX (MAP0004, Orally Inhaled DHE) in Healthy Volunteers: Co-administration of LEVADEX with a potent CYP3A4 inhibitor showed no effects on the plasma levels of DHE or its elimination. Therefore, the potential for potent CYP3A4 inhibitors to enhance or prolong the pharmacological effects of orally inhaled DHE appears to be minimal.
- Assessment of the Consistency of Pharmacokinetic Parameters of LEVADEX (MAP0004, Orally Inhaled DHE) in Healthy Volunteers – Results from 3 Clinical Studies: Pooled analyses assessing the clinical pharmacokinetics of LEVADEX and its primary metabolite across three recent clinical studies show consistent pharmacokinetic results and rapid absorption via the pulmonary route of administration.
- An Open-Label, Two-Period Crossover Study Comparing the Pharmacokinetics and Tolerability of LEVADEX (MAP0004, Orally Inhaled DHE) and Intravenous DHE (DHE45(Ã‚®)) in Smoking and Non-Smoking Adult Volunteers
- 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
- Migraine Recurrence Rates: Case for Standardizing the Definition
All poster presentations are presented at the Grand Hyatt Hotel in Washington, DC from 11:30 a.m. on Thursday, June 2 through 2:30 p.m. on Saturday, June 4. Authors will stand by their posters to answer questions during the following times: Friday, June 3, 12:45 p.m. – 2:00 p.m. and Saturday, June 4, 1:00 p.m. – 2:15 p.m. All times are Eastern Time.
LEVADEX is an investigational acute drug for migraine. The Company has submitted a New Drug Application to the U.S. Food and Drug Administration for the potential acute treatment of migraine in adults. In the clinical trial, patients administered LEVADEX themselves using the proprietary TEMPO(Ã‚®) 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 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 March 31, 2011, available at http://edgar.sec.gov.
CONTACTS: Nicole Foderaro Lisa Borland MAP Pharmaceuticals, WCG Inc. (415) 946-1058 650-386-3122 firstname.lastname@example.org
SOURCE MAP Pharmaceuticals, Inc.