MAP Pharmaceuticals,
Inc. announced today that its Tempo(TM) Migraine drug candidate met its
primary endpoints in a Phase 2 clinical program consisting of two separate
trials. The candidate is a proprietary orally inhaled formulation of
dihydroergotamine (DHE) for the treatment of acute migraine.
The first Phase 2 study demonstrated clinically significant results in
a randomized, outpatient, placebo-controlled study at nine U.S. headache
centers. In addition, a second Phase 2 clinical trial indicated that Tempo
Migraine was well tolerated by subjects with impaired pulmonary function.
In the first Phase 2 study, Tempo Migraine showed statistically
significant pain relief at 2 hours and sustained pain relief at 24 hours
compared to placebo in the treatment received population. In addition,
Tempo Migraine demonstrated statistically significant pain relief at 10
minutes. While this study was powered on pain relief, it showed clinically
significant trends in the resolution of phonophobia, photophobia, and
nausea, reaching statistical significance at certain timepoints. No
statistically significant drug related increase in nausea was observed.
Furthermore, Tempo Migraine demonstrated statistically significant total
migraine relief (from a composite score of the four main symptoms of
migraine) versus placebo at 60 minutes and sustained relief at 24 hours for
subjects receiving treatment. Tempo Migraine was also shown in the study to
be well tolerated, with no serious adverse events reported, including
cardiovascular or respiratory adverse events.
A second Phase 2 study was carried out to evaluate pulmonary delivery
of the drug in adults with compromised pulmonary function. The study was a
randomized, double-blind, placebo-controlled, crossover study of Tempo
Migraine in adult asthmatics. The trial demonstrated that the therapy was
well tolerated by asthmatics with no serious adverse events reported. The
pharmacokinetic profile in adult asthmatics was shown to be similar to
non-asthmatic subjects receiving treatment in an earlier Phase 1
pharmacokinetic study conducted by the company.
"We are pleased to report that our Phase 2 studies using Tempo Migraine
demonstrated potential clinical benefits of fast onset, sustained relief,
and safety," said Stephen B. Shrewsbury MD, Vice President of Clinical and
Regulatory Affairs at MAP Pharmaceuticals. "In this Phase 2 trial, we
determined an effective dose in migraineurs to take into pivotal Phase 3
studies after discussions with the FDA at our scheduled End of Phase 2
meeting. We would like to thank the clinical investigators for their
support, which was a key element to the successful implementation of these
Phase 2 studies."
"Our migraine therapy is demonstrating for the first time that relief
can potentially be achieved within 10 minutes with sustained relief over a
24-hour period," said Timothy S. Nelson, Chief Executive Officer of MAP
Pharmaceuticals. "The results of this Phase 2 study underscore our efforts
to provide fast onset, long lasting, and convenient therapy to patients who
are suffering from acute migraines."
The company plans to present the results from this study at a future
scientific conference. Earlier this week, the company announced that its
pediatric asthma candidate also met its primary efficacy endpoint in a
Phase 2 clinical trial and that it also expects to enter into Phase 3
clinical studies later this year.
About Tempo Migraine
MAP Pharmaceuticals is developing a series of inhaled respiratory and
systemic drug products delivered with the Tempo(TM) Inhaler platform. The
first of these products is a systemic migraine treatment that is designed
to provide faster and more consistent relief than current therapeutics. In
early human studies, Tempo Migraine delivered therapeutic blood levels
within minutes of inhalation, similar to those seen after intravenous
injection. This performance will potentially allow Tempo Migraine to mimic
both the therapeutic blood levels and efficacy of injectable therapy --
offering fast relief without injections. By providing rapid onset with a
novel formulation of a proven compound (dihydroergotamine mesylate), MAP
Pharmaceuticals seeks to meet the treatment needs of the large, underserved
population of migraine sufferers with Tempo Migraine.
About Migraine
About 32 million people in the United States and 33 million people in
Western Europe suffer from migraine headaches. This represents
approximately 18% and 6% of the female and male populations, respectively.
Migraines are a painful neurological disorder with symptoms that typically
include an intense and disabling headache that is episodic. They are
usually characterized by moderate to severe throbbing pain on one or both
sides of the head. Migraine attacks usually involve nausea and sometimes
vomiting, and many sufferers experience extreme sensitivity to light and
sound. Migraines can occur at any age, but they usually begin between the
ages of 10 and 40 and diminish after the age of 50. Prevalence is higher in
women than men, with the highest rates of migraine occurring in women
between the ages of 25 to 35. Most migraines last 4 to 24 hours, although
some may last up to 3 days. In the U.S., less than half of all migraine
sufferers seek treatment from a physician, making this a significantly
underserved and potentially underestimated market. Nevertheless, revenues
for specifically prescribed migraine treatments, including triptans and
ergots, are in excess of $2 billion within the U.S. and $3 billion
worldwide.
About MAP Pharmaceuticals, Inc.
Located in Mountain View, California, MAP Pharmaceuticals, Inc. is a
privately-held, biopharmaceutical company focused on developing novel
treatments for respiratory and CNS diseases. The Company has recently
completed studies as part of two Phase 2 clinical development programs
involving a proprietary formulation of nebulized budesonide for the
potential treatment of children with asthma, and a proprietary formulation
of an inhaled ergot alkaloid delivered by the Company's proprietary Tempo
Inhaler, for the potential treatment of migraines. Additional information
about MAP Pharmaceuticals can be found at mappharma.
MAP Pharmaceuticals, Inc.
mappharma