MAP Pharmaceuticals Announces Completion of Enrollment in Phase 3 Clinical Trial of MAP0004 in Patients with Migraine
"In our Phase 2 clinical trial, MAP0004 demonstrated the potential to beboth fast acting and long-lasting, providing pain relief in as fast as tenminutes with relief lasting for 24 and 48 hours, so we believe that MAP0004has the potential to be a first-line therapy for migraine patients. We wouldlike to thank our investigators as well as their patients for their stronginterest and support for studying the potential benefits of MAP0004," saidTimothy S. Nelson, President and Chief Executive Officer of MAPPharmaceuticals. "We look forward to announcing clinical data from theefficacy portion of the trial in the first half of this year."
The Phase 3 multi-center, randomized, double-blind, placebo-controlledtrial in approximately 850 migraine sufferers is evaluating the safety andefficacy of MAP0004 as a potential acute treatment for migraine. The primaryefficacy endpoints are pain relief and freedom from nausea, photophobia andphonophobia as measured at two hours after dosing. The study is alsoevaluating earliest onset of pain relief, pain relief at 10 minutes, andsustained pain relief and freedom at 24 and 48 hours. Patients enrolled inthe trial are being evaluated for the treatment of a single migraine and maycontinue in a long-term safety arm of the trial, enrollment in which isongoing. MAP Pharmaceuticals is conducting this first Phase 3 trial pursuantto a Special Protocol Assessment (SPA) with the U.S. Food and DrugAdministration.
MAP0004 is a novel, orally inhaled acute migraine medication indevelopment which has a multi-targeted mechanism of action, utilizes thecompany's proprietary TEMPO(R) inhaler and is designed to optimize the keycharacteristics of dihydroergotamine, an active ingredient which has been usedto effectively and safely treat migraines for over 60 years. MAP0004 has thepotential to provide a faster onset of action than currently availablemigraine treatments, with sustained pain relief and pain freedom, in aneasy-to-use, non-invasive, at-home therapy. In a Phase 2 clinical trial,patients reported pain relief in as fast as 10 minutes, with sustained reliefto 24 and 48 hours. The safety data generated to date have shown MAP0004 to bewell tolerated with no significant adverse events reported.
Migraine is a common, debilitating neurological disease affectingapproximately 30 million people in the United States, according to theNational Headache Foundation (NHF). Common symptoms include recurrent attacksof headaches, nausea, vomiting and sensitivity to light and sound. Accordingto the NHF, most migraines last between four and 24 hours, but some last aslong as three days. On average, migraine sufferers experience 1.5 migraineattacks monthly, although 25 percent of them experience one or more attacksweekly, according to published studies.
About MAP Pharmaceuticals, Inc.
MAP Pharmaceuticals is dedicated to developing and commercializing newtherapies for children and adults suffering from chronic conditions that arenot adequately treated by currently available medicines. The company has twoproduct candidates in Phase 3 clinical trials. Unit Dose Budesonide is beingdeveloped for the potential treatment of asthma in children, and MAP0004 isbeing developed for the potential treatment of migraine. MAP Pharmaceuticalsgenerates new pipeline opportunities by applying its proprietary drug particleand inhalation technologies to enhance the therapeutic benefits of provendrugs, while minimizing risk, by capitalizing on their known safety, efficacyand commercialization history.
In addition to statements of historical facts or statements of currentconditions, this press release contains forward-looking statements, includingwith respect to the development, therapeutic potential, and potential safetyand efficacy of MAP Pharmaceuticals' MAP0004 product candidate. Actualresults may differ materially from current expectations based on risks anduncertainties affecting the company's business, including, without limitation,risks and uncertainties relating to the enrollment, conduct, completion andreporting of clinical trials, as well as risks relating to failure to achievefavorable clinical outcomes, and that MAP0004 will not be approved forcommercial use by the United States Food and Drug Administration. The readeris cautioned not to unduly rely on the forward- looking statements containedin this press release. MAP Pharmaceuticals expressly disclaims any intent orobligation to update these forward-looking statements, except as required bylaw. Additional information on potential factors that could affect MAPPharmaceuticals' results and other risks and uncertainties are detailed in itsQuarterly Report on Form 10-Q, filed with the SEC on November 13, 2008, andavailable at http://edgar.sec.gov.
SOURCE MAP Pharmaceuticals, Inc.
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