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
About LEVADEX®
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