MOUNTAIN VIEW, Calif.,
Dec. 21, 2010 /PRNewswire-FirstCall/
-- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced
completion of the LEVADEX™ open-label safety trial.
The Company has now completed the final trial necessary to
support a New Drug Application (NDA) for LEVADEX and plans to
submit an NDA in the first half of 2011. LEVADEX is a novel
orally inhaled migraine therapy that has completed Phase 3 clinical
development for the acute treatment of migraine.
"We are pleased to have completed the LEVADEX clinical program.
This clinical trial completes a comprehensive 505(b)(2) clinical
development program which evaluated the efficacy, safety,
pharmacokinetics and pharmacodynamics of LEVADEX in approximately
1,000 patients," said Timothy S.
Nelson, president and chief executive officer of MAP
Pharmaceuticals. "In 2010, we announced that a second Phase 3 trial
would not be necessary for our NDA submission, completed and
announced successful results from a pharmacokinetics trial in
smokers, a pharmacodynamics trial evaluating pulmonary artery
pressure and a thorough QT trial, and we have now completed our
open-label safety trial."
The 12 month open-label, safety extension of the Phase 3
FREEDOM-301 trial was designed to evaluate overall safety of
LEVADEX over six and 12 months of exposure. In total, more
than 475 patients completed six months treatment and more than 250
patients completed 12 months treatment. In this trial no
drug-related serious adverse events were reported.
The Company anticipates presenting safety results from the trial
at an upcoming scientific conference.
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, preservative-free 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 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 to 3 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 an emerging biopharmaceutical company
focused on developing and commercializing new therapies to address
undermet patient needs in neurology. The Company is developing
LEVADEX orally inhaled therapy for the potential treatment of
migraine and has reported positive results from the efficacy
portion of its 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 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 September 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) 215-5643
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nfoderaro@wcgworld.com
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SOURCE MAP Pharmaceuticals, Inc.