The Phase 2 clinical trial will be conducted in up to ten sites in the United States as a randomized, double-blind, placebo-controlled study in approximately 100 migraine patients. The efficacy of three doses of MAP0004 will be assessed, with the primary endpoint for the trial being pain relief at 2 hours. Additional endpoints include relief from nausea, phonophobia and photophobia. Safety evaluations will be made throughout the clinical trial period.
"DHE, available for 60 years, has been used effectively for decades as an IV infusion and is often required by patients who have not responded to less invasive options such as oral triptans. Injectable DHE remains a popular choice with neurologists who rely on its high efficacy rate, and is also used to treat cluster headaches and transformed migraine where oral triptans are less effective," said Dr. Stephen B. Shrewsbury, Vice President of Clinical and Regulatory Affairs at MAP Pharmaceuticals. "We believe the potential benefit of the non-invasive administration and predicted rapid onset of pharmacological action, ease of use and tolerability provided by our inhaled therapy is well-suited for offering migraine relief in the outpatient setting. Data from this important clinical trial will guide us in our future development of this novel therapy."
Clinical data from a Phase 1 trial completed earlier this year with MAP0004 demonstrated blood levels consistent with efficacious IV infusion and a safety profile that supported initiation of this Phase 2 trial.
"This is an important step for MAP as we have progressed our pre-clinical and clinical development to reach this significant milestone," said Timothy S. Nelson, CEO of MAP Pharmaceuticals. "By providing rapid systemic levels of a proven compound, our migraine therapy seeks to meet the treatment needs of a large, underserved group of migraine sufferers. The results of the earlier Phase 1 clinical trial and the initiation of this Phase 2 trial today underscore MAP's ongoing commitment to, and investment in, developing new treatment options with clear benefits for patients who suffer from acute migraine."
About Acute Migraine Headaches
According to the National Headache Foundation, approximately 30 million people in the United States suffer with migraine headaches. Acute migraine headaches occur often, averaging one to four times per month. MAP Pharmaceuticals believes that migraine sufferers desire fast acting and more reliable therapies for the treatment of their migraine headaches. The American Migraine Study (AMS) II (1999), which covered 20,000 households, reported that 18% of females and 6% of males registered symptoms consistent with migraine. The study also reported that only 48% of these individuals had been diagnosed by a physician. The AMS II Study stated that only 41% of the responding migraineurs were receiving prescriptions for their migraines; this despite the fact that 91% of individuals suffering from migraine described functional impairment, 53% conveyed severe attacks requiring bed rest and 31% reported absence of at least one day from work or school during the previous quarter. These statistics are indicative of the underserved nature of migraine treatment and the need for alternative and improved methods of treatment.
About Tempo(TM) Inhaler
MAP's Tempo(TM) Inhaler is a proprietary, breath synchronized plume controlled inhaler. The Tempo Inhaler automatically adjusts to each patient's unique inspiration pattern, without electronics, and is exceptionally easy to use, enhancing compliance. The Tempo Inhaler also features a novel aerosol flow controller that ensures efficient and consistent delivery to the lungs, reducing dose to dose variation while minimizing oral deposition of the delivered drug.
About MAP Pharmaceuticals, Inc.
Located in Mountain View, California, MAP Pharmaceuticals is a specialty pharmaceutical company focused on the development of innovative therapies and inhalation delivery systems to treat a broad range of respiratory and systemic diseases. MAP's lead product candidates are a proprietary formulation of inhaled DHE for the treatment of migraines and a proprietary formulation of budesonide for the treatment of asthma in both pediatric and adult populations. Additional information about MAP Pharmaceuticals can be found on the MAP website at http://www.mappharma.com.
Source: MAP Pharmaceuticals, Inc.
