MOUNTAIN VIEW, Calif., Sept. 8 /PRNewswire-FirstCall/ — MAP
Pharmaceuticals, Inc. (Nasdaq:
MAPP) today announced that all non-asthmatic patients and a
subset of asthmatic patients have completed 12 months of treatment
in the open-label safety trial of LEVADEX™. In addition, the
Company has completed patient treatment in a thorough QT trial, the
last trial necessary to support a New Drug Application (NDA) for
LEVADEX. At this time, all patients have been enrolled in the
Company’s clinical trials in support of an NDA, which the Company
expects to submit in the first half of 2011. LEVADEX is a
novel orally inhaled migraine therapy that has completed Phase 3
efficacy development for the acute treatment of migraine.
The Company also gave an update of its LEVADEX clinical
development program:
Open-label safety trial: To date, more than 400 patients
have completed at least six months of treatment and more than 200
patients have completed twelve months of treatment. All
non-asthmatic patients and a subset of asthmatic patients have
completed treatment. The remaining patients are expected to
complete treatment in 2010. The Company and an independent
data monitoring committee (DMC) recently completed an interim
safety review of all patients, including asthmatics. In this trial,
LEVADEX has been well tolerated and no drug-related serious adverse
events have been reported. To date, no clinically significant
trends have been reported for LEVADEX in the evaluation of
cardiovascular measurements (as measured by electrocardiogram,
echocardiogram and chest x-ray) and pulmonary function (as measured
by DLco and FEV1). This 12 month open-label, long- term safety
extension of the Company’s Phase 3 FREEDOM-301 trial is designed to
evaluate overall safety of LEVADEX in at least 300 patients for six
months and 150 patients for 12 months, including asthmatics.
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