MAP Pharmaceuticals to Report Additional Subpopulation Data From FREEDOM-301 Trial at the Annual Meeting of the American Academy of Neurology
MOUNTAIN VIEW, Calif., April 7 /PRNewswire-FirstCall/ -- MAP
Pharmaceuticals, Inc. (NASDAQ:MAPP) today announced the Company will
present additional post-hoc analyses from the FREEDOM-301 Phase 3
trial of its investigational LEVADEX(TM) orally inhaled migraine
therapy in two patient subpopulations that are often difficult to
treat with current triptan migraine therapies: menstrual migraine
and migraine with allodynia. The data will be presented at the
Annual Meeting of the American Academy of Neurology (AAN) in
Toronto, Ontario on Wednesday, April 14, 2010. A summary of the
company's AAN presentations is below and the abstracts can be
accessed at the AAN website at www.aan.com.
Evaluation of Safety and Efficacy of MAP0004 in Treating Acute Menstrual Migraine Session Info: Scientific Sessions: Headache II, 4:15-5:30 p.m. ET Presentation Info: Wednesday, April 14, 2010 at 4:30 p.m. ET Presentation #: S35.002 Evaluation of Efficacy and Safety of MAP0004 in Reversing Central Sensitization and Treating Migraine in Established Allodynic Patients Session Info: Poster Session IV: Headache and Facial Pain, 3:00-7:30 p.m. ET Presentation Info: Wednesday, April 14, 2010 at 3:00 p.m. ET Poster #: P04.007 The Timing of Gastric Stasis in an Acute Migraine and its Impact on Treatment Session Info: Poster Session IV: Headache and Facial Pain, 3:00-7:30 p.m. ET Presentation Info: Wednesday, April 14, 2010 at 3:00 p.m. ET Poster #: P04.008 About LEVADEX(TM)
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, menstrually related
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 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/.
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.
CONTACT: Lisa Borland of MAP Pharmaceuticals, Inc.,
+1-650-386-3122,
lborland@mappharma.com; or
Nicole Foderaro of WCG, +1-415-946-1058,
nfoderaro@wcgworld.com, for MAP
Pharmaceuticals, Inc.
Web Site: http://www.mappharma.com/
http://www.aan.com/
Posted: April 2010
