MOUNTAIN VIEW, Calif.,
July 13 /PRNewswire-FirstCall/ -- MAP
Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced results from a
clinical trial comparing the pharmacokinetics (PK) and safety of
LEVADEX™ orally inhaled migraine therapy with intravenous
dihydroergotamine mesylate (DHE) in smokers and non-smokers. The
trial was designed to measure whether systemic absorption and
exposure in smokers is greater than in non-smokers. In the trial,
the systemic absorption of LEVADEX was not higher and systemic
exposure to DHE was not greater in smokers than in non-smokers.
LEVADEX is a novel orally inhaled migraine therapy that has
completed Phase 3 efficacy development for the acute treatment of
migraine.
The PK trial was a single dose, open-label, crossover trial
designed to compare the PK of LEVADEX to intravenous DHE (IV DHE)
in both smokers and non-smokers. In the trial, subjects were
randomized to receive either a single dose of LEVADEX or IV DHE
(DHE 45) and then crossed over to the alternate treatment.
Study drug administration was followed by 48 hours of serial blood
sample collections, repeat ECGs, spirometry and vital sign
assessments. The trial included healthy adult volunteers, 23
were smokers and 24 were non-smokers. LEVADEX was
well-tolerated and no drug related serious adverse events were
reported.
"We are pleased to have completed our PK trial with these
results," said Timothy S. Nelson,
president and chief executive officer of MAP Pharmaceuticals. "In
addition, we are pleased to report that we have completed
enrollment in our pharmacodynamic trial as we continue to make
progress with our remaining clinical trials to support an NDA
submission for LEVADEX in the first half of 2011."
This PK trial is the first trial completed of the four remaining
trials required to support a new drug application (NDA) submission
for LEVADEX. The other trials include an ongoing 12 month
open-label safety extension of the Phase 3 FREEDOM-301 trial, a
pharmacodynamic trial and a thorough QT trial. The Company
anticipates that subjects in these trials will complete treatment
in 2010.
About LEVADEX™
LEVADEX orally inhaled migraine therapy is in Phase 3
development for the potential acute treatment of migraine. Patients
administer LEVADEX themselves using the Company's proprietary
TEMPO® inhaler. In the Phase 3 FREEDOM-301 trial, LEVADEX met all
four co-primary endpoints at two hours: pain relief (p <
0.0001); phonophobia free (p < 0.0001); photophobia free (p <
0.0001); and nausea free (p = 0.02). LEVADEX was well tolerated and
there were no drug-related serious adverse events reported in the
trial. Data from this Phase 3 trial show the potential for LEVADEX
to be effective in treating acute migraine, as well as a broad
spectrum of migraine subpopulations that are often difficult to
treat with current therapies, including triptans. For example, in
this trial, patients with allodynia, menstrual migraine, migraine
with nausea and vomiting, severe migraine or who treated late in
their migraine cycle responded well to LEVADEX.
LEVADEX is a novel formulation of dihydroergotamine mesylate
(DHE), a drug used intravenously in clinical settings to
effectively and safely treat migraines. It is designed to be
differentiated from existing migraine treatments. 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 other DHE-based products and other
currently available migraine 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, and 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 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 enrollment, 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
March 31, 2010, available at
http://edgar.sec.gov.
CONTACTS:
|
|
Lisa
Borland
|
|
MAP
Pharmaceuticals, Inc.
|
|
(650)
386-3122
|
|
lborland@mappharma.com
|
|
|
|
Nicole
Foderaro
|
|
WCG
|
|
(415)
946-1058
|
|
nfoderaro@wcgworld.com
|
|
|
SOURCE MAP Pharmaceuticals, Inc.