MOUNTAIN VIEW, Calif.,
Nov. 8, 2010 /PRNewswire-FirstCall/
-- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today reported
successful results from a thorough QT trial of its investigational
LEVADEX™ orally inhaled migraine therapy. The trial evaluated
the potential of a supra-therapeutic dose to cause an increase in
the QT interval. Results of the trial showed that a
supra-therapeutic dose of LEVADEX does not increase QTc intervals.
LEVADEX is a novel orally inhaled migraine therapy that has
completed Phase 3 efficacy development for the acute treatment of
migraine.
"We are pleased that these results support our previous findings
of cardiac safety from our long term open label and
pharmacodynamics trials," said Timothy S.
Nelson, president and chief executive officer of MAP
Pharmaceuticals. "We continue to anticipate submitting our NDA in
the first half of 2011."
This trial was a randomized, double-blind, placebo-controlled,
three-way, crossover trial in 54 healthy adults comparing the acute
effects of a supra-therapeutic dose of LEVADEX (approximately three
times the anticipated commercial dose), oral moxifloxacin (400 mg)
and placebo on the cardiac QT interval as measured by
electrocardiogram. Moxifloxacin is a positive control known
to increase the QT interval.
For the supra-therapeutic dose of LEVADEX, the largest mean
difference from placebo in QTc (using the individual correction
method for heart rate, or QTci) was 0.08 milliseconds, and the
largest one-sided 95% upper confidence bound was 2.24 milliseconds.
The threshold level of regulatory concern is when the change
produced by a drug has a 95% upper confidence bound that exceeds 10
milliseconds. The number of subjects with individual QTc
intervals > 450 milliseconds and increases in QTc from baseline
> 30 milliseconds were similar to placebo. Moxifloxacin,
the positive control, produced QT prolongation consistent with
previous thorough QT trials.
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 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 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 September 30, 2010, available at
http://edgar.sec.gov.
CONTACTS:
|
|
Alex Bowie
|
|
WCG
|
|
(212) 301-7201
|
|
abowie@wcgworld.com
|
|
|
SOURCE MAP Pharmaceuticals, Inc.