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.
- Thorough QT trial: The Company has completed treatment
in a randomized, double-blind, placebo controlled, three-way,
crossover trial in approximately 54 healthy adults that will
evaluate whether LEVADEX has an effect on QT interval as measured
by electrocardiogram. The objectives of the trial are to compare
the acute effect of LEVADEX, moxifloxacin and placebo on the QT
interval and assess the tolerability of a supratherapeutic dose of
LEVADEX. The Company anticipates releasing results from this trial
in the fourth quarter of 2010.
- Pharmacodynamics (PD) trial: This completed trial
showed that there was no statistically significant difference
between the LEVADEX orally inhaled migraine therapy and placebo
groups in the primary endpoint of pulmonary artery pressure over
two hours after administration. Pulmonary artery pressure in
the IV DHE group was higher than both the LEVADEX and placebo
groups. The PD trial was a randomized, double blind, placebo
controlled, three-way, crossover trial in healthy adults, comparing
the acute effects of LEVADEX, IV DHE and placebo on pulmonary
artery pressure.
- Pharmacokinetics (PK) trial: This completed trial showed
that the systemic absorption of LEVADEX was not higher and systemic
exposure to DHE was not greater in smokers than in non-smokers.
This single dose, open-label, crossover trial compared the PK of
LEVADEX to intravenous DHE (IV DHE) in both smokers and
non-smokers.
About LEVADEX™
LEVADEX orally inhaled migraine therapy is a novel migraine
therapy in Phase 3 development. Patients administer LEVADEX
themselves using the company's proprietary TEMPO® inhaler. LEVADEX
has been designed to be differentiated from existing migraine
treatments. It is a novel formulation of dihydroergotamine (DHE), a
drug used intravenously in clinical settings to effectively and
safely treat migraines. Based on clinical results, the company
believes that LEVADEX has the potential to provide both fast onset
of action, sustained pain relief and other migraine symptom relief
in an easy-to-use and non-invasive at-home therapy.
LEVADEX is designed to incorporate the multiple beneficial
mechanisms of action that allow DHE to block initiation of
migraine, limit pain, reduce inflammation and stop a migraine at
any point in the migraine cycle. Based on research to date,
including the efficacy portion of the FREEDOM-301 trial, the
company believes the unique pharmacokinetic profile of LEVADEX has
the potential to effectively treat migraines, while minimizing the
side effects commonly seen with DHE and other currently available
medicines.
About Migraine
Common symptoms of migraine include recurrent headaches, nausea,
vomiting, photophobia (sensitivity to light) and phonophobia
(sensitivity to sound). According to the National Headache
Foundation, most migraines last between four and 24 hours, but some
last as long as three days. On average, migraine sufferers
experience 1.5 migraine attacks monthly, although 25 percent of
them experience one or more attacks weekly, according to published
studies. Migraine patients report that currently approved drugs do
not fully meet their needs due to slow onset of action, short
duration of effect, inconsistent response and unacceptable side
effect profiles. The economic burden of migraine remains
substantial despite existing treatments, with the direct and
indirect costs of migraine in the United
States estimated at over $20
billion annually.
About MAP Pharmaceuticals
MAP Pharmaceuticals is dedicated to developing and
commercializing new therapies for patients suffering from
conditions that are not adequately treated by currently available
medicines. The Company is developing LEVADEX inhaled therapy for
the potential treatment of migraine and has reported positive
results from the efficacy portion of the first Phase 3 trial of
LEVADEX. In addition, MAP Pharmaceuticals generates new pipeline
opportunities by applying its proprietary drug particle and
inhalation technologies to enhance the therapeutic benefits of
proven drugs, while minimizing risk by capitalizing on their known
safety, efficacy and commercialization history.
Additional information about MAP Pharmaceuticals can be found at
http://www.mappharma.com.
Forward-Looking Statements
In addition to statements of historical facts or statements of
current conditions, this press release contains forward-looking
statements, including with respect to MAP Pharmaceuticals' LEVADEX
product candidate. Actual results may differ materially from
current expectations based on risks and uncertainties affecting the
Company's business, including, without limitation, risks and
uncertainties relating to the conduct and completion of clinical
trials, and relating to the preparation and filing of a New Drug
Application and the regulatory process to have the Company's
LEVADEX product candidate approved for commercial use. The reader
is cautioned not to unduly rely on the forward-looking statements
contained in this press release. MAP Pharmaceuticals expressly
disclaims any intent or obligation to update these forward-looking
statements, except as required by law. Additional information on
potential factors that could affect MAP Pharmaceuticals' results
and other risks and uncertainties are detailed in its Quarterly
Report on Form 10-Q for the quarter ended June 30, 2010, available at
http://edgar.sec.gov.
CONTACTS:
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Nicole
Foderaro
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WCG
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(415)
946-1058
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nfoderaro@wcgworld.com
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SOURCE MAP Pharmaceuticals, Inc.
Copyright t. 8 PR Newswire