MOUNTAIN VIEW, Calif.,
June 2, 2011 /PRNewswire/ -- MAP
Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced that the
Company will present safety data on LEVADEX® 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®)
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.
About LEVADEX®
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® 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