MOUNTAIN VIEW, Calif.,
Oct. 29 /PRNewswire-FirstCall/ -- MAP
Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced new data from
the FREEDOM-301 Phase 3 trial of its investigational LEVADEX™
orally inhaled migraine therapy showing low recurrence rates with
LEVADEX. Eight additional analyses from the LEVADEX program also
will be presented during the 2010 European Headache and Migraine
Trust International Congress (EHMTIC) in Nice, France.
Physicians commonly use the term recurrence to assess the
sustained action of a migraine drug. However, there is not a
standard definition of recurrence, and different methods are used
in the clinical setting to calculate recurrence rates. This
analysis calculated recurrence rates using four different
definitions from the literature to illustrate the variability of
using this endpoint for comparing different migraine
treatments.
"Recurrence rate is one of the main attributes that physicians
rely on to assess the sustained effects of acute migraine
therapies. However, the way in which recurrence is defined
can vary widely," said Shashidhar H.
Kori, M.D., Vice President, Clinical Development and Medical
Affairs of MAP Pharmaceuticals. "While a standard definition would
help make these comparisons more meaningful, data from this
analysis showed low recurrence rates with LEVADEX regardless of the
definition used."
In the poster titled "Migraine Recurrence Rates: Case for
Standardization of the Definition," LEVADEX had a low recurrence
rate at both 24 and 48 hours irrespective of the definition used.
Two large meta-analyses have calculated the cumulative recurrence
rate for triptans to be 22 percent and 29 percent over 24 hours.
Using the same definition, this analysis found LEVADEX to have a
recurrence rate of 6.5 percent over 24 hours and 10.3 percent over
48 hours. No 48 hour recurrence data was reported in the triptan
analyses. Factors found to affect the rate of recurrence in the
triptan meta-analyses include gender of the patient, age group
(below 35 and above 35), and severity of headache pain at the time
of treatment (moderate vs. severe). In this analysis, both age and
severity of pain at time of treatment were associated with higher
recurrence rates in the placebo group.
A second new analysis, "The Major Metabolite of
Dihydroergotamine (DHE) After Oral Inhalation and IV Administration
Does Not Significantly Contribute to the Pharmacological Activity,"
analyzed results of two studies and showed that the pharmacologic
contribution of DHE's primary metabolite is minimal.
The seven other analyses to be presented include:
- LEVADEX, a Novel Orally Inhaled Treatment for Acute Migraine:
Efficacy and Tolerability Results of a Phase 3 Study (#462)
- Efficacy Evaluation of LEVADEX in Treating a Broad Spectrum of
Acute Migraine Attacks (#463)
- Efficacy Evaluation of LEVADEX in Treating Resistant Migraine
Including Migraine with Allodynia, Morning Migraine, Disabling
Migraine and Migraine Treated Late (#464)
- Utility of LEVADEX in Situations Where Early Intervention
Paradigm is Impractical (#322)
- Evaluation of Safety and Efficacy of LEVADEX (MAP0004) in
Treating Acute Menstrual Migraine (#465)
- Evaluation of Efficacy and Safety of LEVADEX (MAP0004) in
Reversing Central Sensitization and Treating Migraine in
Established Allodynic Patients (#466)
- The Efficacy and Tolerability of LEVADEX (Orally Inhaled DHE)
for the Treatment of Migraine in Subjects with Concomitant Asthma
(#467)
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 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 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 . 29 PR Newswire