MOUNTAIN VIEW, Calif.,
June 23, 2011 /PRNewswire/ -- 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.
Abstract #: A-345-0001-00616
Poster presentations will be available on the Publications
section of MAP Pharmaceuticals' website at http://www.mappharma.com
by the conclusion of the Congress.
About LEVADEX®
LEVADEX is an investigational 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® 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