Jun 23 2011
MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced that LEVADEX® orally inhaled migraine drug will be featured in four poster presentations, including one late-breaker presentation, at the 15th Congress of the International Headache Society (IHC) in Berlin, Germany on June 23-26, 2011. LEVADEX is an investigational 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.
The posters will be presented on Friday, June 24, 4:00-5:00 p.m. CET during Poster Shift 1:
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.
Abstract #: Late breaking 648
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.
Abstract #: A-345-0001-00565
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.
Abstract #: A-345-0001-00611
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.
SOURCE MAP Pharmaceuticals, Inc.