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 http://www.mappharma.com.
MAP Pharmaceuticals, Inc.
http://www.mappharma.com
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